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Title:
METHOD OF USING RADIOTHERAPY PARAMETERS FOR CLINICAL STUDIES ON ORAL MUCOSITIS
Document Type and Number:
WIPO Patent Application WO/2024/079462
Kind Code:
A1
Abstract:
The invention provides a method of diagnosing or aiding in the diagnosis of radiation- induced oral mucositis (RIOM) in a subject, wherein the subject is preparing to receive, or has previously received, a mean radiation dose of about at least 10 grey (Gy) to an organ- at-risk (OAR) including but not limited to oral pharyngeal, extended oral cavity, buccal mucosa, lips, palates, gum, and tongue, the method comprising determining the grade of OM severity based on various data and diagnosing the subject with RIOM if the grade is equal to or higher than 1 according to the international consensus grading system for OM. The invention also provides a pharmaceutical composition for use in treating or preventing radiation-induced oral mucositis (RIOM) on a subject in need thereof, the composition comprising one or more of various active agents, wherein the subject has an OM grade for an OAR area examined of a grade 3 or lower according to the WHO or RTOG or CTCAE grade guide; or an OM grade for an OAR area examined of a grade 3 or lower according to the WHO or RTOG or CTCAE grade guide and one or more of the OAR has been assigned a grade X.

Inventors:
LI NINGFENG FIONA (GB)
Application Number:
PCT/GB2023/052637
Publication Date:
April 18, 2024
Filing Date:
October 11, 2023
Export Citation:
Click for automatic bibliography generation   Help
Assignee:
VASODYNAMICS LTD (GB)
LI NINGFENG FIONA (GB)
International Classes:
A61B5/00; A61K31/00; A61K36/886
Other References:
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VERA-LLONCH, M.OSTER, G.FORD, C. M..LU, J.SONIS, S.: "Oral mucositis and outcomes of allogeneic hematopoietic stem-cell transplantation in patients with hematologic malignancies", SUPPORT CARE CANCER., vol. 15, no. 5, 2007, pages 491 - 496, XP019518602, DOI: 10.1007/s00520-006-0176-9
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YUEN, A. H. L.LI, A. K. L.MAK, P. C. Y.LEUNG, H. L..: "Implementation of web-based opensource radiotherapy delineation software (WORDS) in organs at risk contouring training for newly qualified radiotherapists: quantitative comparison with conventional one-to-one coaching approach", BMC MED EDUC., vol. 21, no. 564, 2021, pages 1 - 8
Attorney, Agent or Firm:
GILL JENNINGS & EVERY LLP (GB)
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Claims:
CLAIMS 1. A method of diagnosing or aiding in the diagnosis of radiation-induced oral mucositis (RIOM) in a subject, wherein the subject is preparing to receive, or has previously received, a mean radiation dose of about at least 10 grey (Gy) to an organ-at-risk (OAR) including but not limited to oral pharyngeal, extended oral cavity, buccal mucosa, lips, palates, gum, and tongue, and wherein the method comprises: (a) determining the grade of OM severity based on data previously obtained from the subject, wherein the data includes (i) oral mucositis (OM) scoring parameters for the OAR, the parameters comprising erythema, colour change in mucosa to white or pallor, detachment of epithelium from small ulcerative lesions (sporadic and non-contiguous), white pseudo membrane covering surface, widespread ulcerative lesions over subsites by > 1.5 cm, easy bleeding from ulcerative lesions with contact, spontaneous bleeding from ulcerative lesions, necrosis of ulcerative surface, and mucosa not evaluable according to the Radiation Therapy Oncology Group (RTOG) and NCI-CTCAE; and (ii) oral intake status for the subject according to the WHO Common Terminology Criteria for Adverse Events (CTCAE) grade guide (grade 0 to 4); (b) diagnosing the subject with RIOM, if the grade is equal to or higher than 1 according to the international consensus grading system for OM. 2. The method of claim 2, wherein the OM scoring grades comprise an additional grade X, wherein grade X corresponds to a condition wherein the mucosa is not evaluable. 3. The method of claims 1 or 2, wherein the method comprises an additional step after step (ii), wherein this step comprises obtaining subject reported information for OM, wherein the information comprises data on mouth pain, speaking difficulty, restriction of speech, eating difficulty, restriction on eating, drinking difficulty, swallowing difficulty, and change in taste.

4. The method according to any one of claims 1-3, wherein oral mucositis (OM) scoring parameters are recorded for extended oral cavity, buccal mucosa, lips, tongue and palate. 5. The method according to any one of claims 1-4, wherein the oral intake grading system comprises an additional grade Y, wherein grade Y is defined as requiring nasal and/or gastric tube feeding with the main causes being nausea and dysphagia instead of oral mucositis. 6. The method according to any one of claims 1-5, wherein assessing RIOM severity includes determining a factual radiation dose received on oral mucosa tissue relative to severity levels of oral mucositis secondary to radiation damage. 7. A pharmaceutical composition for use in treating or preventing radiation- induced oral mucositis (RIOM) on a subject in need thereof, the composition comprising one or more of the following selected from aloe vera, aminothiol molecules and/or compounds such as amifostine, cysteamine, N- acetylcysteine, PrC-210, PrC-211, and PrC-252, cryotherapy, granulocyte colony stimulating factor (G-CSF), intravenous glutamine, honey, keratinocyte growth factor, laser irradiation, polymyxin/ tobramycin / amphotericin (PTA) antibiotic tablet / paste, sucralfate, supersaturated calcium phosphate, sodium phosphate, natural and homeopathic agents, any molecules that directly or indirectly protect cellular damage caused by Reactive Oxygen Species (ROS), such as superoxide dismutase mimetic including but not limited to avasopasem manganese and rucosopasem manganese, any inhibitors of nitric oxide synthases such as linear and cyclic N,S-substituted isothioureas and derivatives thereof, any vasoconstrictors such as clonidine and salts thereof, any antibacterial or antimicrobial agent or an agent that can disrupt a microbial environment and/or biofilm, any antifungal agent, any immune modulating agent, any anti-infective agent, any anti-inflammatory agent, and/or any analgesic, and wherein the subject has (i) an OM grade for an OAR area examined of a grade 3 or lower according to the WHO or RTOG or CTCAE grade guide; or (ii) an OM grade for an OAR area examined of a grade 3 or lower according to the WHO or RTOG or CTCAE grade guide and one or more of the OAR has been assigned a grade X. 8. The pharmaceutical composition for use of claim 7, wherein the subject receives individualised radiotherapy schedules without increasing toxicity on OAR. 9. The pharmaceutical composition for use of claim 8, wherein the pharmaceutical composition comprises 0.9 mg/ml to 15 mg/ml L-epinephrine or salts thereof; and a carrier vehicle comprising ethanol and water; wherein the pharmaceutical composition has a molecular oxygen concentration of less than 5% wt/vol; and wherein the pharmaceutical composition has a pH of less than 3. 10. The pharmaceutical composition for use of any one of claims 7-9, wherein the subject is preparing to receive a mean dose of about at least 2 Gy on at least one organ-at-risk (OAR), wherein the OAR is extended oral cavity, buccal mucosa, lips, tongue, gum and palates. 11. The pharmaceutical composition for use of any one of claims 7-10, wherein treatment comprises determining the effectiveness of the pharmaceutical composition in preventing or reducing the severity of radiation-induced: (a) inflammatory mucosal lesions and ulcerations in an organ-at-risk (OAR), (b) dermatitis, and/or (c) hair loss in the subject. 12. The pharmaceutical composition for use of any one of claims 7-11, wherein the OM grade of all OAR examined is a grade 2 or lower according to the WHO or RTOG or CTCAE grading guidelines but not within the definition of grade X and the oral intake status is 0, 1, 2 or Y. 13. The pharmaceutical composition for use of any one of claims 7-12, wherein, the mean radiation dose received or planned is between about 10 and 70 Gy.

14. The pharmaceutical composition for use of claim 13, wherein the mean radiation dose received or planned is about 10-50 Gy, preferably wherein the mean radiation dose received or planned is 30 Gy or above. 15. The pharmaceutical composition for use of claim 7-14, wherein the subject has a benign or malignant medical condition. 16. The pharmaceutical composition for use of claim 15, wherein the malignant condition is cancer, optionally wherein the cancer is selected from a list comprising head and neck cancer, breast cancer, cervix cancer, prostate cancer, and eye cancer, melanoma, skin basal cell carcinoma (BCC), neuroblastoma, non-Hodgkin lymphoma (NHL), Brain tumour and neuroblastoma, Various types of cancers and their metastasis cancers. Spinal cord tumours and spine tumours, Leukaemia, Lymphoma and Hodgkin's lymphoma, Melanoma, Chordoma, Ewing's sarcoma, Mesothelioma, Osteosarcoma, Meningioma, Soft tissue sarcomas, Haemangioma, Chondrosarcoma, Adenomas. 17. The pharmaceutical composition for use of claim 16, wherein the benign condition is selected from the list comprising benign raised scars (benign keloids), non-cancerous benign tumours, Mesothelioma, Graves ophthalmopathy, or thyroid eye disease, Orbital pseudotumor, Meningioma, Trigeminal neuralgia and fibroelastoma, Acoustic neuroma or schwannomas and Heterotopic bone formation, Arteriovenous malformations, and Bone malignancies. 18. The pharmaceutical composition for use of any one of claims 7-17, wherein the subject (i) concurrently receives radiotherapy, chemoradiotherapy, immunotherapy or any other therapy; and/or (ii) has previously been exposed to treatment with chemotherapy, immunotherapy or any other therapy.

19. The pharmaceutical composition for use of any one of claims 7-18, wherein the pharmaceutical composition is for administration as a mouth rinse, and optionally is retaining in the oral cavity for 1-2 minutes before extrapolation. 20. The pharmaceutical composition for use of any one of claims 7-19, wherein the pharmaceutical composition is for administration within 60 minutes prior to the subject receiving fractional irradiation, with or without concomitant other therapies. 21. The pharmaceutical composition for use of any one of claims 7-20, wherein the subject has received cisplatin-based chemoradiotherapy. 22. The pharmaceutical composition for use of any one of claims 7-20, wherein the pharmaceutical composition is for administration to the subject prior to and/or during therapy/therapies comprising administration of agents selected from the list comprising 5-Fu, anti-EGFR antibodies, cetuximab or panitunumab, or EGFR-tyrosine kinase inhibitor (TKi), erlotinib or gefinitib, Bleomycin, Cytarabine, Dacarbazine, Docetaxel, Etoposide, Idarubicin, Interferon-α, Mechlorethamine, Paclitaxel, Topotecan, Vincristine, Cyclophosphamide, Dactinomycin, Doxorubicin, Fluorouracil, Ifosfamide, Irinotecan, Nitroureas, Thiotepa, Vinblastine, Vindesine, Amscarine, Carmusine, Carboplatin, Gemcitabine, Interleukin-2, Mercaptopurine, Mitomycin, Procarbazine, Vinorelbine, Busulfan, Chlorambucil, Epirubicin, Hydroxyurea, Melphalan, Methotrexate, Mitoxantrone, and Teniposide.

Description:
Method of Using Radiotherapy Parameters For Clinical Studies On Oral Mucositis FIELD OF THE INVENTION [001] The present invention generally relates to the field of clinical trials within the setting of radiation induced oral mucositis (RIOM). More specifically, the present invention relates to method of assessing, diagnosing, and screening for RIOM. Also, the instant application relates to methods of selecting a subject for inclusion in a clinical trial, wherein the trial is designed to determine the effectiveness of an investigational compound or composition, device, treatment, product, and/or method for preventing RIOM, radiation-induced dermatitis, and/or radiation- induced hair loss in a subject. Also, the instant invention relates to a method of identifying a subject who would be expected to benefit from prophylaxis against RIOM to prevent interruption of food intake and a method of treating radiation- induced oral mucositis (RIOM) in a subject that has previously been assessed, selected, diagnosed and/or identified according to the invention. The invention also relates to a method of predicting mucosal toxicity for an investigational compound or pharmaceutical composition in a subject. BACKGROUND [002] Radiation-induced oral mucositis (RIOM) and chemotherapy-induced oral mucositis (RIOM) occur when irradiation and cytotoxic agent treatments destroy the mucosa basal cells and as a consequence break down the dividing basal cells lining the oral surface, leaving the mucosal tissue open to ulceration and infection. It is the most common, debilitating serious complication of cancer therapy, manifested as erythema, oedema or ulcerative lesions. Oral mucositis is almost always painful, affects eating, sleeping, and speech, increases risk of infection due to open sores in the mucosa, and profoundly affects quality of life and cancer therapy continuity. Most importantly, it often leads to an interruption or discontinuation and change of the radiotherapy (RT) / chemotherapy (CT) regime and consequently decreases the effectiveness of the anti-cancer therapy. [003] Globally, it is estimated that 12 million individual cancer chemotherapy and/or radiation therapy treatments are administered every year; many of these therapies will induce mucositis, alopecia, and dermatitis in treated patients. It is reported that oral mucositis occurs in up to 20% to 40% of adult cancer patients receiving conventional chemotherapy for solid tumours (Jones et al., 2006), about 80% of patients receiving high-dose chemotherapy prior to hematopoietic stem cell transplant (Vera-Llonch et al., 2007) and almost all patients receiving radiation therapy for head and neck cancer (Vera-Llonch et al., 2006). Approximately 500,000 cases of oral mucositis occur in U.S (Oral Mucositis - Epidemiology Forecast to 2025). Chemotherapy-induced oral mucositis is typically less severe and of shorter duration (3-12 days) than that associated with RT (3-12 weeks). The use of concurrent chemotherapy with RT shortens the onset, exacerbates the severity, and prolongs the duration of mucositis (Rosenthal and Trotti, 2009). The typical radiation regimen for HNC patients comprises a dose of 2 Gy per day for 5–7 continuous weeks, with a total cumulative dose of 60–70 Gy (Gautam et al., 2015). [004] Radiation therapy can bring along with it several side effects, including radiation induced hair loss and/or radiation induced dermatitis is a side effect of external beam ionizing radiation. Most commonly, radiation-induced dermatitis is caused by RT for underlying malignancies and prolonged or multiple procedures requiring radiation exposure, such as cancer treatment. However, it may also result from exposure to radiation during interventional procedures such as coronary angiography, embolization procedures, indwelling catheter placements and/or treatment of non-cancerous conditions, e.g., keloid scar treatment. Notably, the severe radiation-induced dermatitis is more likely to occur in patients with certain risk factors such as total radiation doses of greater than 55 Gy, or large individual doses per fraction (greater than 3-4 Gy per dose) (Ranaweera, 2012). [005] Radiation-induced oral mucositis (RIOM) represents a major complication in patients undergoing RT techniques, such as, e.g., intensity-modulated radiotherapy (IMRT), stereotactic body radiation therapy, particle therapy, and high-dose-rate brachytherapy, and occurs in almost all patients treated for cancers of the mouth, oropharynx, and nasopharynx. Generally, RIOM has a chronic course over a 7 weeks’ period usually appearing 2.5 weeks after RT initiation and continues for 2–3 weeks after treatment completion (Liu et al., 2021). It typically begins a cumulative dose about 15 Gy after 10 days and typically reaches full severity at 30 Gy last for weeks even months. Alternatively, ulcerations may arise due to radiation ranging from 2 Gy per day to 70 Gy per radiotherapy regiment treatment. It can also last for 3–4 weeks after the completion of the treatment (Singh and Singh, 2020). [006] Clinically, RIOM is characterised by pain in the oropharynx, dysphagia, language disorders, and nutritional deterioration, which are the consequence of direct mucotoxicity from ionising radiation (Liu et al., 2021). Oral mucositis has been categorised into five stages, grades 0 to 4, wherein 0 corresponds to no mucositis and 4 corresponds to patients being unable to swallow total parenteral nutrition or where tube feeding is necessary (Singh and Singh, 2020). [007] RIOM is particularly difficult to treat in patients who are already physically and psychologically exhausted by the tumoral pathology. Oral mucositis is considered as a dose limiting early effect since it leads to cancer therapy interruption, poor local tumour control, and changes in dose fractionation, which may prolong overall treatment time and compromise local control and overall survival. RIOM side effects include oral pain in 69% of patients, dysphagia in 56% of patients, opioid use in 53% of patients, weight loss of 3–7 kg, feeding tube insertion and hospitalization (ICU admission) in 15% of patients, and modification or interruption of treatment in 11–16% of patients (Maria et al., 2017). Concomitant chemotherapy use increases the incidence and severity of RIOM. Among those who develop RIOM, more than 50% go on to develop severe RIOM that alters their RT planning and schedule (Trotti et al., 2003). [008] Numerous efforts have been made to identify effective agents for the management of oral mucositis caused by chemotherapy in cancer patients. For grade 1 and 2 RIOM, the treatments are mainly concerned with oral care, especially postprandial oral cleaning, mouthwash with saline and nutritional support. Apart from those, patients can also use mucosal protective agents. For grade 3-4 RIOM, in addition to the treatment measures of grade 1 and 2, patients can also add anti- inflammatory drugs, immunoglobulins and hormones (Rahn et al., 1997, Mose et al., 1997). Common interventions include aloe vera, amifostine, cryotherapy, granulocyte colony stimulating factor (G-CSF), intravenous glutamine, honey, keratinocyte growth factor, laser irradiation, polymyxin/ tobramycin / amphotericin (PTA) antibiotic tablet / paste, sucralfate, natural and homeopathic agents, which offer some benefit in terms of the prevention or reduction of mucositis associated to cancer therapy. Among them, cryotherapy, palifermin and sucralfate showed statistically significant benefit in preventing or reducing the severity of mucositis. Palifermin (a truncated human keratinocyte growth factor (KGF)) is the only drug approved to date by the United States Food and Drug Administration (FDA) for the prevention of oral mucositis in patients with blood- system cancers, whilst its use is not recommended routinely in patients treated for solid cancers such as head and neck cancers (De Sanctis et al., 2016). [009] Preparation of a RIOM treatment plan includes outlining in three dimensions (3D) not only of the tumour area and its potential extensions but also any organ-at- risk (OAR) (referred to as Practical Radiotherapy Planning). [0010] Outlining of OARs in 3D and contouring can be a challenge to experienced radiotherapists and time consuming. More recently, web-based open-source radiotherapy delineation software (WORDS) has become more readily available, and has provided a free alternative to a conventional one-to-one coaching approach during OARs contouring. That is, various WORDS platforms, such as eContour, EduCase, Anatom-e, and ProKnow Contouring Accuracy can be used to study, practice, and improve OARs contouring (Yuen et al., 2021). [0011] Various Radiotherapy Contouring Software are being used to date. Cancer centres use the software that comes together with the radiotherapy machine sets. [0012] Various clinical studies have been carried out for the indication of oral mucositis induced by CT and/or RT, however, the clinical trial protocol design and parameters for measuring the outcome are largely lacking suitability and accuracy particularly for the RT settings. Currently, there is no single agent or management regime that has been agreed upon between caregivers that significantly improves RIOM to a clinically relevant and satisfactory standard, which indicates a significant unmet clinical need for many RIOM patients (De Sanctis et al., 2016; Maria et al., 2017; Chaveli-López and Bagán-Sebastián, 2016; Alvariño-Martín and Sarrión-Pérez, 2014). [0013] Completed and ongoing clinical trials relating to the prevention of oral mucositis (e.g., NCT05055726, NCT03387774, NCT04699487) have inclusion criteria that only involve patients that have been diagnosed with cancer (histologic or cytologic diagnosis) and who are about to start RT, with or without concomitant CT, or patients with starting RT and with no oral mucositis (OM) lesion at the time of inclusion, will be eligible. Currently, patients are being selected for clinical trial based on their cancer status. The advantage of the present invention is that the inclusion criteria is not limited to the cancer, but rather to radiation exposure. [0014] RIOM can cause premature termination of radiation therapy and can alter treatment plans leading to suboptimal treatment doses. Accordingly, there is a need to have a method that allows early selection of those patients that may benefit from RIOM treatment in order to avoid early termination of radiation therapy. Currently, there is no clear-cut and/or well-defined screening approach or precise methodology that allows selection of patients for clinicals trials who are likely to develop RIOM. Accordingly, there is a need for improved methods of identifying those patients that would benefit from treatment of RIOM and who should be included in clinical trials designed to test the benefits of compositions intended to treat or prevent RIOM. SUMMARY OF INVENTION [0015] The present invention generally relates to methods of assessing and diagnosing or aiding in the diagnosis of radiation-induced oral mucositis (RIOM) in a subject. Furthermore, the present invention relates to methods of screening for radiation-induced oral mucositis (RIOM) in a subject, wherein the subject is preparing to receive, or has previously received, a mean radiation dose of about at least 10 grey (Gy) to an OAR. It is envisaged that the OAR will be the location of the RIOM. While, according to current practice, patients are selected for clinical trials based on their cancer status, the inventors have discovered that any patients may be recruited for clinical trial as long as they have received RT on certain OAR areas and that a more informative method would involve analysing the RIOM status at the OAR, which is currently not used for screening patients for clinical trials. The inventors have developed an approach wherein the cancer status of the patient is irrelevant as long as the area (an OAR area) has received radiation. Accordingly, patients are selected for clinical trial based on their likelihood of developing RIOM in consideration of the detailed structure of the organ at risk rather than their cancer status. Notably, the concept of OAR has only been used to treat cancer patients, but not for selecting or recruiting patients for clinical trial. The inventors have discovered that any patient can be recruited as long as they have received a certain radiation exposure. Accordingly, the present invention also relates to methods of selecting a subject for inclusion in a clinical trial, wherein the trial is designed to determine the effectiveness of an investigational compound, or pharmaceutical composition, for preventing, or reducing the severity of radiation-induced inflammatory mucosal lesions and ulcerations in an OAR, dermatitis, and/or hair loss in the subject. [0016] Moreover, the inventors have discovered that the amount of radiation a subject receives can be used to select subjects for clinical trials. Hence, the present invention also relates to methods of identifying a subject who would be expected to benefit from prophylaxis against RIOM to prevent interruption of food intake, wherein the subject is expecting to receive, or has previously received, a mean radiation dose of at least about 10 grey (Gy) to an organ-at-risk (OAR). Additionally, the inventors have developed a novel grading system and an oral mucositis (OM) scoring table that allows a more efficient selection of patients for clinical trials. In that respect, the inventors have also developed a further method of recording and providing patient reported outcomes for RIOM clinical trial protocol design. [0017] Therefore, the problem solved by the instant application generally lies in the provision of improved methods for identifying and selecting subjects to be included in clinical trials wherein the trial is designed to determine the effectiveness of an investigational compound or composition, device, treatment, product and/or method for preventing or reducing the severity of radiation-induced mucosal lesions, dermatitis and/or hair loss. Specifically, the present invention provides for enhanced methods of assessing and screening of those patients that will benefit from treatment in order to prevent premature termination of radiation therapy and change in treatment plans leading to suboptimal treatment doses and efficacy. [0018] The solution to the problem addressed by the instant application of how to provide improved techniques for analysing, diagnosing, and assessing radiation induced oral mucositis (RIOM) severity in a subject and selecting patients to be included in clinical trials wherein the trial is designed to determine the effectiveness of an investigational compound or composition, device, treatment, product or method for preventing or reducing radiation-induced inflammatory mucosal lesions and ulcerations in an OAR, dermatitis, and/or hair loss in the subject is achieved by the embodiments described herein and defined by the appended claims. [0019] The present invention discloses the clinical trial design involving the use of radiotherapy planning and dosimetry to define the radiation exposure level on the specified organ-at-risk (OAR). That is, the invention relates to the methods of designing clinical trials within clinical radiotherapy settings with the radiation exposure delineation on certain specified OAR areas. The invention also discloses the assessment of specific OARs and their use for the clinical trial design to enable accurate readouts on safety and efficacy profiles of an investigational drug, a product or therapy. [0020] The invention utilises existing clinical radiotherapy planning parameters, in particular, the delineation of OAR, which defines the essential OARs including external oral cavity, buccal mucosa and lips to define the radiation exposure levels in order to identify subjects with a likelihood of developing RIOM for clinical trials on RIOM indication. Subsequently, the invention discloses a method of monitoring the essential OARs radiation exposure mean doses in combination with oral mucositis scoring methods used by clinicians and patient reported outcomes for RIOM clinical trial protocol design. [0021] In addition, the invention discloses the method of using RIOM scoring in the first week of radiotherapy as the toxicity monitoring parameter for the investigational drugs using vasoconstrictors as active drug substances. [0022] The present invention discloses a clinical trial design involving using radiotherapy planning and dosimetry to define the radiation exposure level on certain specified OAR areas. The invention also discloses the specific OARs used for the clinical trial design to enable accurate readouts on safety and efficacy profiles of an investigational drug, a product or therapy. [0023] The invention utilises the clinical radiotherapy planning parameters, in particular, the delineation of OAR including the essential OARs such as external oral cavity, buccal mucosa and lips to define the radiation exposure levels for clinical studies within the context of RIOM. [0024] Subsequently, the invention discloses the method of monitoring the essential OARs radiation exposure (mean doses) in combination with the oral mucositis scoring methods by clinicians using the digital 3D radiation modelling and contouring software and/or by patients’ reports for RIOM clinical trial protocol design. [0025] In addition, the invention discloses the method of using RIOM scoring in the first week of radiotherapy as the dose-limiting toxicity monitoring parameter for safety assessment on an investigational drug using a vasoconstrictor as active drug substance. [0026] In a first aspect provided herein is a method of diagnosing or aiding in the diagnosis of radiation-induced oral mucositis (RIOM) in a subject, wherein the subject is preparing to receive, or has previously received, a mean radiation dose of about at least 10 grey (Gy) to an organ-at-risk (OAR) including but not limited to oral pharyngeal, extended oral cavity, buccal mucosa, lips, palates, gum, and tongue, and wherein the method comprises: (a) determining the grade of OM severity based on data previously obtained from the subject, wherein the data includes (i) oral mucositis (OM) scoring parameters for the OAR, the parameters comprising erythema, colour change in mucosa to white or pallor, detachment of epithelium from small ulcerative lesions (sporadic and non-contiguous), white pseudo membrane covering surface, widespread ulcerative lesions over subsites by > 1.5 cm, easy bleeding from ulcerative lesions with contact, spontaneous bleeding from ulcerative lesions, necrosis of ulcerative surface, and mucosa not evaluable according to the Radiation Therapy Oncology Group (RTOG) and NCI- CTCAE; and (ii) oral intake status for the subject according to the WHO Common Terminology Criteria for Adverse Events (CTCAE) grade guide (grade 0 to 4); (b) diagnosing the subject with RIOM, if the grade is equal to or higher than 1 according to the international consensus grading system for OM. [0027] In a second aspect provided herein is a pharmaceutical composition for use in treating or preventing radiation-induced oral mucositis (RIOM), the composition comprising one or more of the following selected from aloe vera, aminothiol molecules and/or compounds such as amifostine, cysteamine, N-acetylcysteine, PrC-210, PrC- 211, and PrC-252, cryotherapy, granulocyte colony stimulating factor (G-CSF), intravenous glutamine, honey, keratinocyte growth factor, laser irradiation, polymyxin/ tobramycin / amphotericin (PTA) antibiotic tablet / paste, sucralfate, supersaturated calcium phosphate, sodium phosphate, natural and homeopathic agents, a molecule that directly or indirectly protects against cellular damage caused by Reactive Oxygen Species (ROS), such as superoxide dismutase mimetics including but not limited to avasopasem manganese and rucosopasem manganese, a inhibitor of nitric oxide synthase, such as linear and cyclic N,S-substituted isothioureas and derivatives thereof, a vasoconstrictor such as clonidine and salt thereof, an antibacterial, and/or antimicrobial reagent, or a reagent that is capable of disrupting a bacterial or microbial biofilm, an antifungal agent, an immune modulating reagent, an agent capable of preventing and/or reducing an infection, inflammation and/or pain, and wherein the subject has (i) an OM grade for an OAR area examined of a grade 3 or lower according to the WHO or RTOG or CTCAE grade guide; or (ii) an OM grade for an OAR area examined of a grade 3 or lower according to the WHO or RTOG or CTCAE grade guide and one or more of the OAR has been assigned a grade X. BRIEF DESCRIPTION OF DRAWINGS [0028] The figure shown in the following is merely illustrative and shall describe the present invention in a further way. The figures shall not be construed to limit the present invention thereto. [0029] Fig.1 represents an illustration of the axial (left) and sagittal (right) view of consensus delineations for different Organs at risk (OAR). The OAR structures numbered are (1) parotid glands (2) pharyngeal constrictor muscles (3) carotid arteries (4) spinal cord (5) mandible (6) extended oral cavity (7) buccal mucosa (8) lips (9) brain (10) chiasm (11) pituitary gland (12) brainstem (13) supraglottic larynx (14) glottic area (15) cricopharyngeal inlet (16) cervical esophagus and (17) thyroid. DETAILED DESCRIPTION [0030] In order that the present invention may be more readily understood, certain terms are first defined. [0031] The articles "a" and "an" are used herein to refer to one or to more than one (i.e., to at least one) of the grammatical object of the article. By way of example, "an element" means one element or more than one element, e.g., a plurality of elements. [0032] The terms "about" and "approximately" may be understood to permit standard variation as would be understood by those of ordinary skill in the art. [0033] The term “including” is used herein to mean, and is used interchangeably with, the phrase “including, but not limited to”. Likewise, the term “comprising” is used herein to mean, and is used interchangeably with, the phrase “comprising, but not limited to". [0034] The term “Grey” (Gy) as used herein refers to international system (SI) unit of radiation dose expressed in terms of absorbed energy per unit mass of tissue. It is defined as the absorption of one joule of radiation energy per kilogram of matter. [0035] The term “organ-at-risk” (OAR) as defined by the ICRU (International Committee for Radiological Units) refers to the healthy or normal tissues which lie adjacent to tumours and may therefore be included within treated volumes, with a risk that the radiation may impair their normal functioning. In other words, the OAR refers to the tissues and/or organs placed near the clinical target volume (CTV) whose irradiation could cause damage that would make changes to the radiotherapy treatment plan. Preparation of a treatment plan involves outlining in 3D not only tumour but also its potential extensions, but also OAR. The organ as risk may include, for example, one or more organs such as extended oral cavity, buccal mucosa, lips, tongue, gums and palate. In one embodiment, the OAR is oral cavity. In one embodiment, the OAR is buccal mucosa. In one embodiment, the OAR is lips. In one embodiment, the OAR is tongue. In one embodiment, the OAR is gums. In one embodiment, the OAR is palate. In one embodiment, the OAR can be a combination of one or more OAR. For example, the OAR assessed can be oral cavity, buccal mucosa, lips, tongue and palate. [0036] The term “radiation induced oral mucositis” or “RIOM” refers to common tissue injury and a debilitating complication caused by radiation/radiotherapy (RT). However, many risk factors have been identified for RIOM. These risk factors include, among others, concomitant chemotherapy (CT). RIOM can be a major dose-limiting toxicity. It begins after cumulative exposure to 15 Gy and worsens markedly if total dose exceeds 60 Gy. Hence, in some embodiments, the subject has received a cumulative exposure of 15 Gy. [0037] The term “ulceration” as used herein refers to ulcers, which are wounds caused by the acute or chronic effects of ionizing radiation. The injury may involve the skin, underlying soft tissue, and even deep structures such as bone. The most common cause of radiation injury is an adverse effect of therapeutic radiation therapy. [0038] The term “inflammatory mucosal lesions” or “mucositis” as used herein refers to a medical condition wherein injury to the oral mucosa results in increased vascular permeability, tissue oedema, atrophy, and eventually ulcerations that may be covered by a necrotic pseudo-membrane in some instances. Bleeding may be associated with more advanced lesions. Mucositis is most often associated with chemotherapy and administration of radiation therapy in the treatment of cancer. It tends to occur in the first 2 weeks of therapy. In cancer treatment it may lead, amongst others, to compromised nutritional intake, a delay in drug administration, life-threatening septicaemia. [0039] The term “tolerance dose(s)” refers to the general correlation of risk of side effects with dose distribution using a TD5/5 table, which provides an estimate of radiation dose which gives a 5% chance of injury showing up over the next 5 years after radiation treatment. Also, TD50/5 is considered, which provides information on 50% chance of injury. Nowadays, the advent of 3D planning has made it possible to describe a dose given to a volume of tissue and to correlate it with acute and late effects. This description is usually in a form of Dose-Volume Histogram (DVH). A DVH is a plot of radiation dose on the x-axis and percent volume of a structure of interest on the y-axis. Based on DVH, the concept of biologically effective dose (BED) equation has been developed to evaluate the biological effects corrected to radiation dose received. For each individual organ and tissue, the combination of TD5/5, TD50/5 and DVH or mean dose in Gy determines the tolerance dose in Gy. [0040] The term “intensity-modulated radiotherapy” or “IMRT” refers to a type of conformal radiotherapy that shapes the photon and proton radiation beams to closely fit and/or conform to the area of a cancer. The goal of IMRT is to conform the radiation dose to the target and to avoid or reduce exposure of healthy tissue to limit the side effects of treatment. [0041] The term “gross tumour volume” (GTV) refers to the primary tumour and all areas of potential microscopic disease and/or tumour mass shown by clinical examination, at examination under anaesthetic (EUA), or by imaging. Thus, the GTV may consist of primary tumour and/or metastatic lymphadenopathy or distant metastases. GTV always contains the highest tumour cell density and is absent after complete surgical resection. GTV is classified by staging systems such as TNM (UICC), AJCC, or FIGO. [0042] As used herein, the term “clinical target volume” (CTV) refers to the grossly detectable tumour volume plus any microscopic tumour that extends outward from the grossly involved margins. That is, it contains the GTV and/or subclinical microscopic disease that has to be eradicated to cure the tumour. CTV can be denoted by the dose level prescribed, e.g., CTV-T50 for a particular CTV given 50 Gy. Consensus guidelines such as those for defining CTV for head and neck nodes (Gregoire et al., 2014) and pelvic nodes (Lim et al., 2011) are used to improve and help CTV delineation. [0043] The term “planning target volume” (PTV) comprises the CTV and GTV and is used in treatment planning to select appropriate beams to ensure that the prescribed dose is actually delivered to the CTV. The PTV is generally determined by clinical oncologists and created from the respective CTVs to account for setup uncertainties. [0044] As used herein the expression “OAR delineation” or “delineation of OAR” refers to tissue contouring of OARs in the radiation therapy treatment planning process. That is, contouring (segmentation) of OARs in medical images is required for accurate radiation therapy (RT) planning and the safety of treatment delivery. It is common general knowledge that contouring guides (i.e., atlases) are published for different anatomic sites to guide practitioners to define clinical target volumes, and should also be used for visualization of tissue parameters. Disease site-specific contouring atlases published by NRG Oncology (commonly known as Radiation Therapy Oncology Group (RTOG) contouring atlases) are developed by consensus among cooperative groups and disease-site committees. [0045] As used herein, the terms “prevent”, “preventing” and “prevention” in the context of the present invention and the administration of a therapy(ies) to a subject refers to the inhibition of the development or onset of a disease or a symptom thereof. In one embodiment, it relates to the administration of the compound to a patient who is known to have an increased risk of developing a certain condition, disorder, or disease. [0046] As used herein, the terms “treat”, “treatment”, and “treating” refer in the context of the present invention to the administration of the compound to a patient, which has already developed signs and/or symptoms of a certain condition, disorder, or disease. Beneficial or desired clinical results include, but are not limited to, alleviation of symptoms; diminishment of the extent of a condition, disorder, or disease stabilized (i.e., not worsening) state of condition, disorder, or disease; delay in onset or slowing of condition, disorder, or disease progression; amelioration of the condition, disorder, or disease state or remission (whether partial or total), whether detectable or undetectable; an amelioration of at least one measurable physical parameter, not necessarily discernible by the patient; or enhancement or improvement of condition, disorder, or disease. Treatment includes eliciting a clinically significant response without excessive levels of side effects. Treatment also includes prolonging survival as compared to expected survival if not receiving treatment. [0047] The terms “subject” or “patient” are used interchangeable and relate to an animal (e.g., mammals) that may need administration of the compound of the invention in the field of human or veterinary medicine. In specific embodiments, the subject is a human. [0048] As used herein the expression “subject is preparing to receive” refers to a subject or patient who has been medically examined and who has been prescribed to receive a specific PTV radical dose as measured in the amount and number of Gy and Fractions to be administered to the patient. Furthermore, the “subject is preparing to receive” refers to those subjects or patients that are to be administered a planned mean dose (Gy) to the organ at risk, for example the extended oral cavity, buccal mucosa, and/or lips, whereby the planned mean dose (Gy) depends on the volume (cm 3 ) of the OAR. [0049] As used herein, the term "pharmaceutically acceptable" means approved by a regulatory agency. The term “carrier” refers to a diluent, adjuvant, excipient, or vehicle with which the pharmaceutical composition is administered. Saline solutions and aqueous dextrose and glycerol solutions can also be employed as liquid carriers, particularly for injectable solutions. Suitable excipients include starch, glucose, lactose, sucrose, gelatine, malt, rice, flour, chalk, silica gel, sodium stearate, glycerol monostearate, talc, sodium chloride, citric acid, dried skim milk, glycerol, propylene, glycol, water, ethanol and the like. The formulation should suit the mode of administration. [0050] As used herein, the terms "disease" and "disorder" are used interchangeably to refer to a condition in a subject. [0051] As used herein, the term "effective amount" in the context of administering a therapy to a subject refers to the amount of a therapy which has a prophylactic and/or therapeutic effect(s ). [0052] As used herein, the term "in combination," in the context of the administration of two or more therapies to a subject, refers to the use of more than one therapy (e.g., more than one prophylactic agent and/or therapeutic agent). The use of the term "in combination" does not restrict the order in which therapies are administered toa subject. [0053] As used herein, the term “Grade X” refers to an additional and new grade introduced by the inventors of the present application in addition to the RTOG grade guide (grades 0-4). Grade X refers to an unidentifiable or undetectable degree of OM severity due to limited visibility to oral cavity and corresponds to “Mucosa not evaluable (flaps, etc.)”. Hence, in some embodiment, the patient is categorised a grade X. [0054] As used herein, the term “Grade Y” refers to an additional and new grading category introduced by the inventors of the present invention in addition to the Oral Mucositis Score of the World Health Organization (WHO), which is classified into 5 grades (grades 0-4) based on the changes of patients' oral mucosa and ability to eat. “Grade Y” was introduced by the inventors to further stratify the grading system and corresponds to the condition wherein subjects or patients “require nasal/gastric tube feeding with the main causes being nausea and dysphagia other than mouth sore”. In some embodiment, the patient is categorised a grade Y. [0055] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. Methods and materials are described herein for use in the present disclosure; other, suitable methods and materials known in the art can also be used. Methods of diagnosing, predicting, and assessing RIOM [0056] Currently, the Radiation Therapy Oncology Group (RTOG) grading is widely used to evaluate the severity of RIOM. However, many scales can be used to evaluate the severity of mucositis, such as the RTOG scale, WHO (World Health Organization) toxicity scale, CTCAE (Common Terminology Criteria for Adverse Events) scale, NCI-CTC (National Cancer institute Common Toxicity Criteria), and WCCNR (Western Consortium for Cancer Nursing Research) stomatitis staging. All scales apply scoring criteria for radiation-induced oral mucositis that range from grade 1 (e.g., erythema and mild symptoms) to grade 4 (e.g., ulceration, necrosis, and bleeding) (Liu et al., 2021). [0057] The present invention relates to methods for assessing RIOM severity in a subject. For example, the present invention describes methods for assessing RIOM severity in a subject, wherein the subject is preparing to receive, or has previously received, a mean radiation dose of about at least 10 grey (Gy) to an OAR. Moreover, the present invention relates to a method of assessing radiation induced oral mucositis (RIOM) severity in a subject, wherein method further comprises recording oral mucositis (OM) scoring parameters for the OAR and determining oral intake status according to the WHO Common Terminology Criteria for Adverse Events (CTCAE) grade guide. [0058] Accordingly, provided herein a method of diagnosing or aiding in the diagnosis of radiation-induced oral mucositis (RIOM) in a subject, wherein the subject is preparing to receive, or has previously received, a mean radiation dose of about at least 10 grey (Gy) to an organ-at-risk (OAR) including but not limited to oral pharyngeal, extended oral cavity, buccal mucosa, lips, palates, gum, and tongue, and wherein the method comprises: (a) determining the grade of OM severity based on data previously obtained from the patient, wherein the data includes (i) oral mucositis (OM) scoring parameters for the OAR, the parameters comprising erythema, colour change in mucosa to white or pallor, detachment of epithelium from small ulcerative lesions (sporadic and non-contiguous), white pseudo membrane covering surface, widespread ulcerative lesions over subsites by > 1.5 cm, easy bleeding from ulcerative lesions with contact, spontaneous bleeding from ulcerative lesions, necrosis of ulcerative surface, and mucosa not evaluable according to the Radiation Therapy Oncology Group (RTOG) and NCI- CTCAE; and (ii) oral intake status for the subject according to the WHO Common Terminology Criteria for Adverse Events (CTCAE) grade guide (grade 0 to 4); (b) diagnosing the patient with RIOM, if the grade is equal to or higher than 1 according to the international consensus grading system for OM. [0059] In one embodiment, described herein is a method of assessing radiation induced oral mucositis (RIOM) severity in a subject, wherein the subject is preparing to receive, or has previously received, a mean radiation dose of about at least 10 grey (Gy) to an organ-at-risk (OAR), wherein the method comprises: (i) determining an oral mucositis (OM) scoring grade (grade 0 to 4) in the subject, wherein the determining comprises recording oral mucositis (OM) scoring parameters for the OAR, wherein the parameters comprise erythema, colour change in mucosa to white or pallor, detachment of epithelium from small ulcerative lesions (sporadic and non-contiguous), white pseudo membrane covering surface, widespread ulcerative lesions over subsites by > 1.5 cm, easy bleeding from ulcerative lesions with contact, spontaneous bleeding from ulcerative lesions, necrosis of ulcerative surface, and mucosa not evaluable according to the Radiation Therapy Oncology Group (RTOG) and NCI-CTCAE; (ii) determining the oral intake status for the subject according to the WHO Common Terminology Criteria for Adverse Events (CTCAE) grade guide (grade 0 to 4); and (iii) determining the grade of OM severity based on the information obtained in steps (i) and (ii), wherein the OM grading system ranges from 0-4; wherein a grade of 0 is indicative of no OM. [0060] Patient-reported outcomes (PROs) provide a mean that allows evaluation of the functioning and health outcomes from the patient's perspective. It is known from the art that patient reporting can improve communication, satisfaction, and symptom management (Koranteng and Moryl, 2017). Hence, in one embodiment, the method comprises an additional step after step (ii), wherein this step comprises obtaining subject reported information for OM, wherein the information comprises data on mouth pain, speaking difficulty, restriction of speech, eating difficulty, restriction on eating, drinking difficulty, swallowing difficulty, and change in taste. [0061] The OARs are the tissues or organs placed near the clinical target volume (CTV) whose irradiation could cause damage that would make changes to the radiotherapy treatment plan. In one embodiment, oral mucositis (OM) scoring parameters are recorded for extended oral cavity, buccal mucosa, lips, tongue, and palate. [0062] Generally, patient may be assessed and diagnosed or selected for inclusion in clinical trials based on the condition of their oral mucosa. According to the invention for the prevention and reduction of severe oral mucositis, any patient having a high grade of 3 or 4 will be excluded from the clinical trials. Patients that have a RTOG score of 0, 1, or 2 for an OAR area or any combination thereof and an oral intake grade of 0, 1, or 2 will be included in the clinical trial (see, Example 1). However, there still is an unmet need in finessing the grading system in order to more efficiently select patients for clinical trials. Particularly, when there is difficulty to visualise the oral cavity in full under certain concomitant condition or operations, additional grading criteria are desired to enable an standardised assessment and recording (see Example 2-3), [0063] Evaluating for oral mucositis is dependent upon clinical history and physical exam findings. In addition to the RTOG grade system, the inventors of the present application have further developed a new “Grade X”. “Grade X” is an additional new grade introduced by the inventors in addition to the RTOG grade guide (grades 0-4) and refers to a higher degree of OM severity and corresponds to “Mucosa not evaluable (flaps, etc.)”. This new grade allows identification of patients whose mucosa is not evaluable but who should still be included in the clinical trial for the treatment of RIOM. Hence, in one embodiment, the condition of the oral mucosa (OM) is not evaluable. In one embodiment, the condition of the oral mucosa is not evaluable because of the severity of the mucositis (e.g., ulcers). In one embodiment, the condition of the oral mucosa is not evaluable at the time when the patient is assessed. In one embodiment, the OM scoring grade guide (e.g., the grades according to the RTOG grade guide) comprise an additional grade X, wherein grade X corresponds to a condition wherein the mucosa is not evaluable (flaps, etc.). In one embodiment, the OM scoring grades comprise an additional grade X or Y. In one embodiment, the OM scoring grades consist of grades 0, 1, 2, 3, 4, X and Y. [0064] In one embodiment, the subject has a scoring grade of grade 0. In one embodiment, the subject has a scoring grade of grade 1. In one embodiment, the subject has a scoring grade of grade 2. In one embodiment, the subject has a scoring grade of grade 3. In one embodiment, the subject has a scoring grade of grade 4. In one embodiment, the subject has a scoring grade of grade X. In one embodiment, the subject has a scoring grade of grade Y. Depending on the type and number of OARs assess the skilled person understands that a single subject may have different scoring grades for different OARs. [0065] Accordingly, in one embodiment, the patient has been assigned a grade X for an OAR. In one embodiment, the OM highest grade for an OAR area of a subject is X. In one embodiment, the subject has an OM grade X for at least one of the OAR areas examined. In one embodiment, the subject has an OM grade X for the extended oral cavity, buccal mucosa, lips, tongue and/or palate. In one embodiment, the subject has an OM grade X for the gums. In another embodiment, all of the OAR areas examined are assigned a grade X. In one embodiment, the subject is eligible to be included in the clinical trial on the basis of grade X. In one embodiment, the subject is eligible to be included in the clinical trial on the basis of grade X and Oral Intake Status (see Example 2). In any embodiment of the invention, it is envisaged that a subject that is eligible to be included in the clinical trial will be included in the clinical trial. [0066] Based on the new grade introduced by the inventors, it is possible to identify those patients that should still be included in the clinical trial for the assessment of potential prevention treatments for RIOM even though the condition is within a grade 4 according to the traditional RTOG or WHO grading due to the nasal and/or gastric tube feeding requirement and oral mucosa not evaluable. If the patient is assigned a grade 0, 1, or 2 or any combination thereof for all OAR the patient is eligible to be included in the clinical trial. If the patient is assigned a grade 0, 1, or 2 for all OAR but one OAR, and said one OAR is assigned a grade X, then the patient will still be eligible to be included in the clinical trial. Hence, in one embodiment, the subject has been assigned a grade X. In one embodiment, the subject has been assigned a grade X and is eligible to be included in the clinical trial. In one embodiment, at least one of the OAR areas has been assigned a grade X and the subject is eligible to be included in the clinical trial. In one embodiment, at least one of the OAR areas has been assigned a grade X, the other OAR areas have been assigned a grade 0, 1, or 2, and the subject is therefore eligible to be included in the clinical trial. It may occur that one or more of the OAR areas has been assigned a grade 3 or 4. It this case, the patient will likely not be eligible to be included in the clinical trial. [0067] Moreover, in addition to the Grade guide provided by the WHO, RTOG and CTCAE, the inventors of the present application have introduced a new grading category (“Grade Y”), which further categorises the oral intake status. This new grade is based on the need of the patient to require nasal or gastric tube feeding. Hence, in one embodiment, the oral intake grading system comprises an additional grade Y, wherein grade Y is defined as requiring nasal and/or gastric tube feeding with the main causes being nausea and dysphagia or shortly after surgery. In one embodiment, the subject has been assigned a grade Y for the oral intake status. In one embodiment, the subject is eligible to be included in the clinical trial on the basis of grade Y. In one embodiment , the oral intake grading system comprises an additional grade Y. In one embodiment, the oral intake grading system comprises an additional grade Y, wherein grade Y is defined as requiring nasal and/or gastric tube feeding with the main causes being nausea and dysphagia instead of oral mucositis. In one embodiment, the main cause for nasal and/or gastric tube feeding is nausea. In one embodiment, the main cause for nasal and/or gastric tube feeding is dysphagia. Hence, in some embodiments, being assigned a grade Y makes the patient eligible for inclusion in the clinical trial. [0068] In one embodiment, the subject has been assigned a grade 0, 1, or 2 according to the RTOG grade guide and a grade 0, 1, or 2 for the oral intake status and hence, is eligible to be included in the trial. In one embodiment, the subject has been assigned a grade 0, 1, or 2 according to the RTOG grade guide and a grade 3 or 4 for the oral intake status and hence, is excluded from the clinical trial, in other words is not eligible to be included in the trial. In one embodiment, the subject has been assigned a grade 0, 1, or 2 according to the RTOG grade guide and a grade Y for the oral intake status and hence, is eligible to be included in the trial. In one embodiment, the subject has been assigned a grade 3 or 4 for the oral intake status and hence, is excluded from the clinical trial. [0069] In one embodiment, the subject has been assigned a highest grade of 0 for one or more OAR areas according to the RTOG and a grade Y for the oral intake status and is thus eligible to be included in the clinical trial. In one embodiment, the subject has been assigned a highest grade of 1 for one or more OAR areas according to the RTOG and a grade Y for the oral intake status and is thus eligible to be included in the clinical trial. In one embodiment, the subject has been assigned a highest grade of 2 for one or more OAR areas according to the RTOG and a grade Y for the oral intake status and is thus eligible to be included in the clinical trial. [0070] In one embodiment, the subject is assigned a grade Y rather than a grade 3 for the oral intake status. In one embodiment, the subject is assigned a grade Y rather than a grade 4 for the oral intake status. In one embodiment, the subject is assigned a grade Y rather than a grade 3 for the oral intake status, and thus, is eligible to be included in the clinical trial. In one embodiment, the subject is assigned a grade Y rather than a grade 4 for the oral intake status, and thus, is eligible to be included in the clinical trial. [0071] In one embodiment, the subject is selected for inclusion in the clinical trial, if (i) the highest OM grade for an OAR area examined is a grade 2 or lower according to the RTOG grade guide; or (ii) the highest OM grade for an OAR area examined is a grade 2 or lower according to the RTOG grade guide and one or more of the OAR has been assigned a grade X. In one embodiment, the oral intake status is a grade 0, 1, 2 or Y (WHO, CTCAE). [0072] In one embodiment, the subject is selected for inclusion in the clinical trial, if the OM grade of all OAR examined is a grade 2 or lower according to the RTOG and the oral intake status is 0, 1, 2 or Y (WHO, CTCAE). [0073] The subject may be excluded from the clinical trial (i.e. deemed not eligible to be included), if a RTOG grade is 3 or higher for any of the OAR areas examined. The subject may be excluded from the clinical trial, if the oral intake is 3 or 4. The subject may be excluded from the clinical trial, if a RTOG grade is 3 or higher for any of the OAR areas examined and the oral intake is 3 or 4. [0074] In one embodiment, assessing RIOM severity includes determining a factual radiation dose received on oral mucosa tissue relative to severity levels of oral mucositis secondary to radiation damage. In one embodiment, it includes reasons other than oral mucosal inflammation. [0075] In one embodiment described herein is a method of diagnosing or aiding in the diagnosis of radiation-induced oral mucositis (RIOM) in a subject, wherein the subject is preparing to receive, or has previously received, a mean radiation dose of about at least 10 grey (Gy) to an OAR, and wherein the method comprises: (a) assessing RIOM severity in the subject according to the invention; (b) diagnosing the patient with RIOM, if the grade is equal to or higher than 1 according to the international consensus grading system for OM. [0076] In one embodiment described herein is a method of screening for radiation- induced oral mucositis (RIOM) in a subject, wherein the subject is preparing to receive, or has previously received, a mean radiation dose of about at least 10 grey (Gy) to an OAR, and wherein the method comprises: (a) assessing RIOM severity in the subject according to the invention; (b) determining RIOM according to the RTOG grade guide, wherein a grade of 1 or higher, is indicative for RIOM. [0077] To include patients with desired radiation exposure levels to the OAR – and in addition to the RTOG grade guide -, a clinical study protocol for studying the oral mucositis (OM) severity is developed to define the inclusion criteria using radiotherapy parameters. Hence, in one embodiment described herein is a method of selecting a subject for inclusion in a clinical trial, wherein the trial is designed to determine the effectiveness of an investigational compound, or pharmaceutical composition, a device, a therapy, or a method for preventing, or reducing the severity of, radiation-induced: (a) inflammatory mucosal lesions and ulcerations in an organ-at-risk (OAR), (b) dermatitis, and/or (c) hair loss in the subject; wherein the method of selecting said subject comprises: (i) recording a planning target volume (PTV) radical dose, a PTV elective dose, an organ-at-risk (OAR) volume, and wherein the OAR is extended oral cavity, buccal mucosa and lips, and a mean radiation dose (Gy) planned; and (ii) selecting the subject for inclusion in the clinical trial, if the subject is preparing to receive a mean dose of about at least 30 Gy on at least one of the OAR listed in (i). [0078] In one embodiment, the inclusion criteria require the patient to be planned to receive a mean radiation dose of no less than 30 Gy on either (a) extended oral cavity, or (b) buccal mucosa, or (c) lips, according to CT-based delineation of Organ- At-Risk (OAR) Guideline with or without concurrent chemotherapy or immunotherapy. In one embodiment, a subject is eligible to be included in the clinical trial of an investigational drug for the reduction or prevention of severe RIOM, if the subject is preparing to receive a mean dose of about at least 30 Gy on the extended oral cavity, buccal mucosa and/or lips. [0079] In one embodiment, the PTV radical dose is 70 Gy in 35 fractions. In one embodiment, the PTV radical dose is 40, 50, 60 or 65 Gy in about 20-35 fractions. In one embodiment, the PTV elective dose is 66.5 Gy in 35 fractions. In one embodiment, the PTV elective dose is 50-70 Gy in about 30-35 fractions. In one embodiment, severe RIOM tends to develop when the radiation exposure is above 30 Gy. [0080] Patients may be identified and selected for inclusion in a clinical trial on RIOM if at least one of the OAR has been assigned to or has received about at least 30 Gy. Hence, in one embodiment, the patient is included in the clinical trial, if said patient is planned to receive a mean radiation dose of no less than 30 Gy on (a) extended oral cavity, (b) buccal mucosa, or (c) lips. [0081] In one embodiment, a subject is selected for inclusion in a clinical trial irrespective of the cancer status and solely based on the mean radiation dose planned. [0082] In one embodiment, the method comprises a step of assessing RIOM severity in the subject according to the invention, and wherein the subject is selected for inclusion in the clinical trial, if the RIOM is of grade 2 or lower according to the World Health Organization (WHO) oral mucositis scale/common toxicity criteria, or Radiation Therapy Oncology Group (RTOG) scale, or National Cancer Institute Common Terminology Criteria (NCI CTC), or Common Terminology Criteria for Adverse Events (CTCAE) grading system for oral mucositis (OM). [0083] In one embodiment, the subject has previously received or is preparing to receive a mean radiation dose of about at least 10 Gy on the OAR. [0084] In one embodiment, the mean radiation dose received or planned is between about 10 and 70 Gy. In one embodiment the mean radiation dose received or planned is about 10-60, about 10-50, about 10-40, about 10-30 Gy. In one embodiment, the mean radiation dose received or planned is about 10-50 Gy. In one embodiment, the mean radiation dose received or planned is about 10, 20, 30, 40, 50, 60, or 70 Gy. In a preferred embodiment, the mean radiation dose received or planned is about 30 Gy. In one embodiment, the mean radiation dose received or planned is not less than about 10, 20, 30, 40, 50, 60, or 70 Gy. [0085] Also, in some cases the mean radiation dose received or planned is below 10 Gy. In one embodiment, the mean radiation dose received or planned is about at least 2 Gy. In one embodiment, the mean radiation dose received or planned is 2 Gy. In one embodiment, the mean radiation dose received or planned is 3 Gy. In one embodiment, the mean radiation dose received or planned is 4 Gy. In one embodiment, the mean radiation dose received or planned is 5 Gy. In one embodiment, the mean radiation dose received or planned is 6 Gy. In one embodiment, the mean radiation dose received or planned is 7 Gy. In one embodiment, the mean radiation dose received or planned is 8 Gy. In one embodiment, the mean radiation dose received or planned is 9 Gy. [0086] In one embodiment, the mean radiation dose received or planned is at least 2 Gy. In one embodiment, the mean radiation dose received or planned is at least 3 Gy. In one embodiment, the mean radiation dose received or planned is at least 5 Gy. In one embodiment, the mean radiation dose received or planned is at least 7 Gy. [0087] In one embodiment, the mean dose (Gy) planned for an OAR is 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56, 57, 58, 59, or 60 Gy. In one embodiment, a patient is assigned a planned mean dose (Gy) of 56.8, 42.5, and 25 Gy for the extended oral cavity, buccal mucosa, and lips, respectively. [0088] It must be noted that the mean radiation dose received or planned can be adapted during treatment or prevention of the patient. [0089] In one embodiment, the inflammatory mucosal lesions and ulcerations are radiation-induced oral mucositis (RIOM). In one embodiment, severe RIOM tends to develop when the radiation exposure is above 30 Gy. In one embodiment, severe RIOM develops when the radiation exposure is above about 30 Gy, 40 Gy, 50 Gy, 60 Gy or 70 Gy. [0090] The subject may have a benign or malignant medical condition. Accordingly, in one embodiment, the subject has a benign or malignant medical condition. In one embodiment, the subject has a benign medical condition. In one embodiment, the subject has a malignant medical condition. In one embodiment, the subject has one or more malignant medical conditions. In one embodiment, the subject has one or more benign medical conditions. [0091] In one embodiment, the malignant condition is cancer, optionally wherein the cancer is selected from a list comprising head and neck cancer, breast cancer, cervix cancer, prostate cancer, and eye cancer, melanoma, skin basal cell carcinoma (BCC), neuroblastoma, non-Hodgkin lymphoma (NHL), brain tumour and neuroblastoma, Various types of cancers and their metastasis cancers. Spinal cord tumours and spine tumours, Leukaemia, Lymphoma and Hodgkin's lymphoma, Melanoma, Chordoma, Ewing's sarcoma, Mesothelioma, Osteosarcoma, Meningioma, Soft tissue sarcomas, Haemangioma, Chondrosarcoma, Adenomas. [0092] In one embodiment, the benign condition is selected from the list comprising benign raised scars (benign keloids), non-cancerous benign tumours, Mesothelioma, Graves ophthalmopathy, or thyroid eye disease, Orbital pseudotumor, Meningioma, Trigeminal neuralgia and fibroelastoma, Acoustic neuroma or schwannomas and Heterotopic bone formation, Arteriovenous malformations, Bone malignancies. [0093] The subject may receive different treatment therapies or combinations thereof in order to treat a medical condition. In one embodiment, the subject (i) concurrently receives radiotherapy, chemoradiotherapy, immunotherapy or any other therapy; and/or (ii) has previously been exposed to treatment with chemotherapy, immunotherapy, or any other therapy. [0094] In the context of medical devices, a clinical trial or can be defined as any systematic investigation or study on one or more human subjects undertaken to assess the safety or performance of a medical device. In some embodiments, the clinical trials are designed, in addition or in the alternative, to determine the effectiveness of medical devices for use in the treatment of patients suffering from oral mucositis (OM). For example, different devices that may be used include but are not limited to, e.g., devices for cryotherapy, laser therapy, phototherapy, photobiomodulation therapy (PBM; use of low-level light and laser therapy to induce a biological response), various light therapy devices, infrared thermometer; physical barrier reagents such as Ection (Ectoin® Mouth Wash), Gelclair® (GEL, medical device indicated for the management of painful oral lesions), FluidCrystal® film and episil®, MuGard, Hyaluronic acid-based gel, MUCIPLIQ; pain control gel such as Dentoxol, Caphosol; and (chemo) mouthpiece device, Bocaliner, MuGard, etc.. In some embodiments, the clinical trial aims to evaluate the feasibility of using a certain device (as listed above) in the treatment of oral mucositis. In some embodiments, the clinical trial aims to evaluate the feasibility or effectiveness of using a device in the treatment of oral mucositis and/or (severe) RIOM. In some embodiments, the clinical trial aims to evaluate a combination of the devices mentioned above. In some embodiments, the trial is designed to determine or evaluate the effectiveness of an investigational compound or composition, device, treatment, product and/or method for preventing or reducing the severity of radiation-induced mucosal lesions, dermatitis and/or hair loss. In some embodiments, the trial is designed to determine or evaluate the effectiveness of an investigational compound or composition, device, treatment, product and/or method for preventing or reducing the severity of RIOM. In one embodiment, a device is assessed for its effectiveness in the treatment of OM in combination with a drug, dietary supplement and/or radiation. [0095] In some embodiments, the trial is designed to determine or evaluate the effectiveness of an investigational compound or composition, device, treatment, product and/or method for preventing or reducing the severity of radiation-induced dermatitis. In some embodiments, the trial is designed to determine or evaluate the effectiveness of an investigational compound or composition, device, treatment, product and/or method for preventing or reducing the severity of radiation-induced hair loss. [0096] In one embodiment described herein is a method of identifying a subject who would be expected to benefit from prophylaxis against RIOM to prevent interruption of food intake, wherein the subject is expecting to receive, or has previously received, a mean radiation dose of at least about 10 grey (Gy) to an organ-at-risk (OAR), and wherein the method comprises: (i) assessing RIOM severity in the subject according to the invention; (ii) optionally diagnosing the patient with RIOM according to the invention; and (iii) selecting the subject for prophylaxis, if (a) the existing highest grade of OM is equal to or lower than 2; or (b) the predicted highest grade of RIOM is equal to or higher than 3. [0097] In one embodiment, the existing highest grade of OM is 0. In one embodiment, the existing highest grade of OM is 1. In one embodiment, the existing highest grade of OM is 2. In one embodiment, the predicted highest grade of RIOM is 3. In one embodiment, the predicted highest grade of RIOM is 4. [0098] Also provided herein is a method of treating radiation-induced oral mucositis (RIOM) in a subject that has previously been assessed, selected, diagnosed and/or identified according to any of the methods of the invention, wherein the method comprises administering to the subject an effective amount of a pharmaceutical composition comprising one or more of the following selected from aloe vera, aminothiol molecules and/or compounds such as amifostine, cysteamine, N- acetylcysteine, PrC-210, PrC-211, and PrC-252, cryotherapy, granulocyte colony stimulating factor (G-CSF), intravenous glutamine, honey, keratinocyte growth factor, laser irradiation, polymyxin/ tobramycin / amphotericin (PTA) antibiotic tablet / paste, sucralfate, supersaturated calcium phosphate, sodium phosphate, natural and homeopathic agents, any molecules directly or indirectly protect cellular damage caused by Reactive Oxygen Species (ROS) such as superoxide dismutase mimetic including but not limited to avasopasem manganese and rucosopasem manganese, any inhibitors of nitric oxide synthases such as linear and cyclic N,S-substituted isothioureas and the derivatives, any vasoconstrictors such as clonidine and salt formats, any reagent having effect on bacterial, microbial environment and/or biofilm, any reagent targeting on fungal infection, any reagent claiming effect on modulating immune response, any reagent for preventing and/or reducing an infection, inflammation and/or pain. In one embodiment, the subject receives individualised radiotherapy schedules without increasing toxicity on OAR. [0099] In one embodiment described herein is a method of predicting mucosal toxicity for an investigational compound or pharmaceutical composition in a subject, and wherein the method comprises determining RIOM scoring in the first week of radiotherapy by assessing radiation-induced oral mucositis (RIOM) severity in the subject according to any of the method of the invention, wherein the RIOM scoring of grade 3 or higher is used as the toxicity monitoring parameter. [00100] Radiotherapy requires the target area and the OARs to be contoured on the CT image of each individual patient. The delineations of large and varied shapes are time-consuming and laborious. Moreover, the OARs contours of the same patient by different doctors tend to be subjectively different. This means, the doctor needs to contour each CT image to diagnose, predict, or assess RIOM. In order to do so, various types of radiotherapy Contouring Software may be used to define the OARs mean radiation dose that is planned to be administered to or received by the subject. For instance, such software includes auto-contouring software DirectORGANS and/or Philips’ TomorLOC. Alternative automatic contour software may include AiContour and/or Raystation automatic delineating system (Chen et al., 2021). Other software includes online accessible contouring software as described in Yuen et al. (2021). In any method of the invention, the determining of and/or defining of the organ at risk may be implemented by a computer. Thus, the invention includes computer implemented method for diagnosis or identifying suitable patients for selection in a clinical trial or for therapy. The computer implemented methods of the invention may comprise the use of the packages discussed above, such as DirectORGANS and/or Philips’ TomorLOC and/or AiContour and/or Raystation. A machine learning algorithm may be trained to recognise and/or define and/or determine organ at risk for use in the methods of the invention. and uses thereof [00101] Described herein are pharmaceutical compositions and their uses in treating and/or preventing radiation-induced oral mucositis (RIOM). The pharmaceutical compositions described herein can be in any form that allows for the composition to be administered to a subject. In a specific embodiment, the pharmaceutical compositions are suitable for human administration. The compositions may be used in methods of preventing or treating radiation-induced oral mucositis (RIOM) in a subject. [00102] In one embodiment, the pharmaceutical composition comprises 0.9 mg/ml to 15 mg/ml L-epinephrine or salts thereof; and a carrier vehicle comprising ethanol and water; wherein the pharmaceutical composition has a molecular oxygen concentration of less than 5% wt/vol; and wherein the pharmaceutical composition has a pH of less than 3. The pharmaceutical composition may comprise hydrochloric acid. The pharmaceutical composition may further comprise glycerol and/or propylene glycol, preferably the carrier vehicle may comprise: from 2% to 10% vol/vol ethanol; from 2% to 10% vol/vol glycerol; from 4% to 12% vol/vol propylene glycol; and from 70% to 90% vol/vol water. The L-epinephrine or salts thereof may be present in the range of 0.9 mg/ml to 11 mg/ml, 0.9 mg/ml to 9 mg/ml, 0.9 mg/ml to 5.5 mg/ml, 1.8 mg/ml to 9 mg/ml, 1.8 mg/ml to 7.5 mg/ml, 2.7 mg/ml to 7.5 mg/ml, or 2.7 mg/ml to 5.5 mg/ml. The pharmaceutical composition may have a molecular oxygen concentration of less than 4.5 % wt/vol, less than 4.0 % wt/vol, less than 3.5 % wt/vol, less than 3.0 % wt/vol, or less than 2.5 % wt/vol, or less than 1% wt/vol. The pharmaceutical composition may further comprise D-epinephrine, DL-epinephrine and/or salts thereof. The pharmaceutical composition may further comprise one or more antioxidants; preferably in an amount of from 0.01 to 0.5% wt/vol; and/or preferably wherein the antioxidant is selected from the group consisting of metabisulfite, citric acid, DL-alpha-tocopherol or combinations thereof. The pharmaceutical composition may further comprise one or more penetration enhancers, preferably wherein the penetration enhancers are selected from Isopropyl myristate or Medium-chain monoglycerides. The pharmaceutical composition may further comprise one or more keratolytic ingredients, preferably wherein the keratolytic ingredient is lactic acid. The pharmaceutical composition may further comprise one or more sweeteners, preferably in an amount of from 0.01 to 5% wt/vol; and/or one or more flavouring agents, preferably in an amount of from 0.05 to 2% wt/vol. The pharmaceutical composition may be formulated as a mouth rinse, gel, balm, oil, paste or aerosol. [00103] The pharmaceutical composition may alternatively comprise: 0.92mg/ml to 36.6mg/ml L-epinephrine or salts thereof; and a carrier vehicle comprising ethanol and water; wherein the pharmaceutical composition has a molecular oxygen concentration of less than 5% wt/vol; and wherein the composition has a pH of less than 3. The pharmaceutical composition may comprise hydrochloric acid. The carrier vehicle may comprise: from 30% to 80% vol/vol ethanol; and from 20% to 70% vol/vol water. The pharmaceutical composition may further comprise one or more antioxidants; preferably in an amount of from 0.01 to 0.5 % wt/vol. The pharmaceutical composition may be formulated as a gel, shampoo, balm, oil, paste or cream. [00104] The pharmaceutical compositions described herein may be used in treating and/or preventing radiation-induced oral mucositis (RIOM). Provided herein is a pharmaceutical composition for use in treating or preventing radiation-induced oral mucositis (RIOM), the composition comprising one or more of the following selected from aloe vera, aminothiol molecules and/or compounds such as amifostine, cysteamine, N-acetylcysteine, PrC-210, PrC-211, and PrC-252, cryotherapy, granulocyte colony stimulating factor (G-CSF), intravenous glutamine, honey, keratinocyte growth factor, laser irradiation, polymyxin/ tobramycin / amphotericin (PTA) antibiotic tablet / paste, sucralfate, supersaturated calcium phosphate, sodium phosphate, natural and homeopathic agents, any molecules directly or indirectly protect cellular damage caused by Reactive Oxygen Species (ROS) such as superoxide dismutase mimetic including but not limited to avasopasem manganese and rucosopasem manganese, any inhibitors of nitric oxide synthases such as linear and cyclic N,S-substituted isothioureas and the derivatives, any vasoconstrictors such as clonidine and salt formats, any reagent having effect on bacterial, microbial environment and/or biofilm, any reagent targeting on fungal infection, any reagent claiming effect on modulating immune response, any reagent for preventing and/or reducing an infection, inflammation and/or pain, and wherein the patient has (i) an OM grade for an OAR area examined of a grade 3 or lower according to the WHO or RTOG or CTCAE grade guide; or (ii) an OM grade for an OAR area examined of a grade 3 or lower according to the WHO or RTOG or CTCAE grade guide and one or more of the OAR has been assigned a grade X. In one embodiment, the patient has (i) an OM grade for an OAR area examined of a grade 3 or lower according to the WHO or RTOG or CTCAE grade guide; or (ii) an OM grade for an OAR area examined of a grade 3 or lower according to the WHO or RTOG or CTCAE grade guide and one or more of the OAR has been assigned a grade X. [00105] In one embodiment, the subject receives individualised radiotherapy schedules without increasing toxicity on OAR. [00106] In one embodiment, the pharmaceutical composition comprises 0.9 mg/ml to 15 mg/ml L-epinephrine or salts thereof; and a carrier vehicle comprising ethanol and water; wherein the pharmaceutical composition has a molecular oxygen concentration of less than 5% wt/vol; and wherein the pharmaceutical composition has a pH of less than 3. [00107] In one embodiment, the subject is preparing to receive a mean dose of about at least 2 Gy on at least one organ-at-risk (OAR), wherein the OAR is extended oral cavity, buccal mucosa, lips, tongue, gum and palates. [00108] In one embodiment, treatment comprises determining the effectiveness of the pharmaceutical composition in preventing or reducing the severity of radiation- induced: (a) inflammatory mucosal lesions and ulcerations in an organ-at-risk (OAR), (b) dermatitis, and/or (c) hair loss in the subject. [00109] In one embodiment, the subject is selected for inclusion in the clinical trial, if the OM grade of all OAR examined is a grade 2 or lower according to the WHO or RTOG or CTCAE grading guidelines but not within the definition of grade X and the oral intake status is 0, 1, 2 or Y. [00110] In one embodiment, the mean radiation dose received or planned is between about 10 and 70 Gy. [00111] In one embodiment, the mean radiation dose received or planned is about 10-50 Gy. In one embodiment, the mean radiation dose received or planned is above 30 Gy. [00112] The pharmaceutical composition for use of the invention may be administered to a patient who has been diagnosed with another medical condition. In one embodiment, the subject has a benign or malignant medical condition. [00113] The pharmaceutical composition for use of the invention may be administered to a patient who has been diagnosed with cancer. In one embodiment, the malignant condition is cancer, optionally wherein the cancer is selected from a list comprising head and neck cancer, breast cancer, cervix cancer, prostate cancer, and eye cancer, melanoma, skin basal cell carcinoma (BCC), neuroblastoma, non- Hodgkin lymphoma (NHL), Brain tumour and neuroblastoma, Various types of cancers and their metastasis cancers. Spinal cord tumours and spine tumours, Leukaemia, Lymphoma and Hodgkin's lymphoma, Melanoma, Chordoma, Ewing's sarcoma, Mesothelioma, Osteosarcoma, Meningioma, Soft tissue sarcomas, Haemangioma, Chondrosarcoma, Adenomas. [00114] In one embodiment, the benign condition is selected from the list comprising benign raised scars (benign keloids), non-cancerous benign tumours, Mesothelioma, Graves ophthalmopathy, or thyroid eye disease, Orbital pseudotumor, Meningioma, Trigeminal neuralgia and fibroelastoma, Acoustic neuroma or schwannomas and Heterotopic bone formation, Arteriovenous malformations, and Bone malignancies. [00115] A patient may receive a combination of therapies. The one or more other therapies may be beneficial in the treatment or prevention of RIOM or another disease, such as cancer, or may ameliorate a symptom or condition associated with RIOM or another disease. In one embodiment, the subject (i) concurrently receives radiotherapy, chemoradiotherapy, immunotherapy or any other therapy; and/or (ii) has previously been exposed to treatment with chemotherapy, immunotherapy or any other therapy. [00116] In one embodiment, the pharmaceutical composition for use of the invention is administrated as mouth rinse retaining in oral cavity for 1-2 minutes before extrapolation. [00117] In one embodiment, the pharmaceutical composition for use of the invention is administrated within 60 minutes before receiving fractional irradiation, with or without concomitant other therapies. In one embodiment, the pharmaceutical composition for use of the invention is administrated within 60 minutes before receiving fractional irradiation with concomitant other therapies. In one embodiment, the pharmaceutical composition for use of the invention is administrated within 60 minutes before receiving fractional irradiation without concomitant other therapies. [00118] In some embodiments, a pharmaceutical composition for use of the invention is administered to a subject in combination with one or more therapies. The one or more other therapies may be beneficial in the treatment of cancer. In one embodiment, the one of more other therapies is an antineoplastic agent or a chemotherapy medication. In one embodiment, the one of more other therapies are pain relievers and/or anti-fever medications. In one embodiment, the subject receives cisplatin-based chemoradiotherapy. [00119] The pharmaceutical composition for use according to the invention may be administered prior to and/or during the administration of one or more other therapies. In another embodiment, the pharmaceutical composition for use of the invention is administrated to patients prior and/or during therapy/therapies using agents selected from the list comprising 5-Fu, anti-EGFR antibodies, cetuximab or panitunumab, or EGFR-tyrosine kinase inhibitor (TKi), erlotinib or gefinitib, Bleomycin, Cytarabine, Dacarbazine, Docetaxel, Etoposide, Idarubicin, Interferon-α, Mechlorethamine, Paclitaxel, Topotecan, Vincristine, Cyclophosphamide, Dactinomycin, Doxorubicin, Fluorouracil, Ifosfamide, Irinotecan, Nitroureas, Thiotepa, Vinblastine, Vindesine, Amscarine, Carmusine, Carboplatin, Gemcitabine, Interleukin-2, Mercaptopurine, Mitomycin, Procarbazine, Vinorelbine, Busulfan, Chlorambucil, Epirubicin, Hydroxyurea, Melphalan, Methotrexate, Mitoxantrone, and Teniposide. [00120] The present invention shall be described in more detail by the following Figures and Examples. EXAMPLES [00121] The examples shown in the following are merely illustrative and shall describe the present invention in a further way. These examples shall not be construed to limit the present invention thereto. Example 1. Using OM scoring table with parameters according to delineation of OAR radiation exposure measurements for selecting eligible subject for RIOM clinical trial. [00122] Apart from specifically measuring the delineated OAR radiation exposure, an accurate oral mucositis (OM) scoring table is generated to enable clinicians record OM assessment outcome with multiple standardised tools. While WHO, RTOG and NCI-CTCAE OM scoring tools are commonly used to assess the oral inflammation and ulceration severity as adverse effect or side-effect of cytotoxic therapies and/or radiotherapy, there is now specific selection and/or inclusion criteria for the clinical trials evaluating the safety and efficacy of drugs for the prevention of oral mucositis. Currently, inclusion criteria are based on the cancer status of the subject, e.g., patients with lymphoma or multiple myeloma planned for receiving chemotherapy. [00123] The inventors of the instant application have developed a new method of selecting subjects that are eligible for participating in clinical trials by combining and assessing different parameters for OAR as indicated in WHO, RTOG and NCI-CTCEA OM scoring tools. That is, apart from specifically measuring the delineated OAR radiation exposure, an accurate oral mucositis (OM) scoring table is generated to enable clinicians to record OM assessment outcome with multiple standardised tools. [00124] As displayed in Figure 1, radiotherapy oncology clinical settings typically use chemotherapy (CT) based imaging for localising the radiation exposure to specific organs and tissues. The radiation tolerability varies from organ to organ, as we well as tissue to tissue. [00125] The inventors submit that it is more accurate to use the guideline specified delineation of organ-at-risk (OAR) radiation exposure to monitor the toxicity in relation to mean radiation exposure on the specific organ(s) and/or tissue(s) than the general total accumulative radiotherapy treatment dose given to a patient. [00126] Endpoint: The primary endpoint of the clinical trial is to investigate the potential to reduce the incidence of severe RIOM (grade 3 and above) or the time to onset of severe RIOM (grade 3 or above) or the duration of severe RIOM (grade 3 and above) in subjects having received or who are planned to receive radiation therapy. [00127] To include patients with desired radiation exposure levels to the OAR, a clinical study protocol for studying the oral mucositis (OM) severity is developed to define the inclusion criteria using radiotherapy parameters. The inventors have specifically developed a new combination of selection criteria for deciding on the inclusion of patients into RIOM clinical trials. [00128] Inclusion/Exclusion criteria: The inclusion criteria have been defined to include any subjects who have received or who are planned to receive radiation therapy and who have an OM grade of 2 or below according to the Oral Mucositis (OM) Assessment Sheet. These subjects are eligible for inclusion into the clinical trial, wherein the trial is designed to determine the effectiveness of an investigational compound in the treatment radiation-induced inflammatory mucosal lesions and ulcerations in an OAR, dermatitis, and/or hair loss. Any subjects who have one or more scores of grade 3 or above according to the Oral Mucositis (OM) Assessment Sheet are not eligible for and are excluded from the clinical trial. [00129] As exemplified in Table 1 below, for subject 1 the highest OM grade according to the RTOG grade guide across all OAR assessed is 1, i.e., Grade 1 for Lips (erythema). The Oral intake status has been assigned a “Grade 1 or 2” according to the WHO, CTCAE. According to this grading, subject 1 is selected for and included in the clinical trial to determine the effectiveness of the investigational compound. [00130] Similarly, as shown in Table 2, subject 2 has a highest OM grade of 2 according to the RTOG grade guide, i.e., grade 2 for Buccal Mucosa [Detachment of epithelium from small ulcerative lesions (sporadic and non-contiguous)]. At the same time, the oral intake status according to the WHO, CTCAE has been assigned a “grade 1 or 2”. Therefore, subject 2 is also selected for and included in the clinical trial to receive the investigational product treatment. [00131] On the other hand, as shown in Table 3, before entering into the clinical trial, subject 3 has been assigned a grade of 3 according to the RTOG grade guide for the Extended Oral Cavity and Buccal Mucosa (i.e., “Widespread ulcerative lesions over subsites by > 1.5cm”). Additionally, the oral intake status has been assigned a “grade 3” according to the WHO, CTCAE. Accordingly, subject 3 will not be included in the clinical trial to receive the investigational product treatment. [00132] The data from the Example shows that the newly generated OM assessment sheet with parameters according to the delineation of OAR radiation exposure measurements can be used to efficiently pre-select patients for clinical trial based on their maximum score according RTOG/WHO/CTCAE grade guide. That is, the inventors have shown that the newly developed OM assessment sheet with parameters according to “delineation of OAR” radiation exposure can be used to select patients based on their likelihood to develop RIOM and/or severe RIOM.

Table 1. OM Assessment Sheet: OM Highest Grade noted for Subject 1: Grade 1; WHO*:___1____; NCI-CTCAE#:____1____. * - WHO = World Health Organisation; OM Highest Grade noted according to the WHO guidelines; * * - RTOG = Radiation Therapy Oncology Group # - NCI-CTCAE = National Cancer Institute-Common Terminology Criteria for Adverse Events (CTCAE)

Table 2. OM Assessment Sheet: OM Highest Grade noted for Subject 2: Grade 2; WHO*: 2 ; RTOG**: 2 ; NCI-CTCAE#: 2 . * - WHO = World Health Organisation; OM Highest Grade noted according to the WHO guidelines; * * - RTOG = Radiation Therapy Oncology Group # - NCI-CTCAE = National Cancer Institute-Common Terminology Criteria for Adverse Events (CTCAE)

Table 3. OM assessment Sheet: OM Highest Grade noted for Subject 3: Grade 3; WHO*:___3___; NCI-CTCAE#:____3____. * - WHO = World Health Organisation; OM Highest Grade noted according to the WHO guidelines; ** - RTOG = Radiation Therapy Oncology Group # - NCI-CTCAE = National Cancer Institute-Common Terminology Criteria for Adverse Events (CTCAE)

Example 2. Introducing Grade X to identify and select individuals for inclusion in clinical trials where the mucosa is not evaluable. [00133] To further refine the WHO, RTOG and NCI-CTCAE OM scoring tools, the inventors of the present application further improved the grading system by introducing a new OM grade into the system, i.e., “Grade X”. This new grade X allows the inventors to identify and grade patients and subsequently select them for inclusion into clinical trials on RIOM even if their mucosa is not evaluable. [00134] In some instances, examination of the oral mucosa is not possible. For example, a Subject 4 relates to a patient who has just completed a facial reconstructive surgery after tumour removal (see, Table 4). In this case, the condition of the oral mucosa is not evaluable at the time when the patient is assessed for enrolment into the clinical trial on prophylactic treatments for RIOM. Accordingly, the patient being assigned a “Grade X” according to the RTOG. At the same time, the patients’ oral food-intake status is considered to range from good oral intake to oral intake being feasible with modifications in seasoning and texture (soft food intake), the patient being ranked a Grade 1 or 2 according to the WHO, CTCAE grade guide. In this case, the oral intake status grading system supplies the foundation of the OM status. Therefore, Subject 4 is scored as Grade 1 or 2, and is eligible for inclusion in the clinical trial on prophylaxis treatments on RIOM (see, Table 4). [00135] The inventors of the application that shown that by introducing a “Grade X” into the OM assessment sheet, subjects may be identified that would otherwise be excluded from enrolment simply due to the inability to evaluate oral mucosa condition after recent surgery. This provides an improved method of assessing and selecting patients for RIOM studies.

Table 4. OM Assessment Sheet: OM Highest Grade noted for Subject 4: Grade 1 NCI-CTCAE#:____1____. * - WHO = World Health Organisation; OM Highest Grade noted according to the WHO guidelines; ** - RTOG = Radiation Therapy Oncology Group # - NCI-CTCAE = National Cancer Institute-Common Terminology Criteria for Adverse Events (CTCAE)

Example 3. Introducing Grade Y to identify individuals who require tube feeding due to reasons unrelated to oral mucositis (OM). [00136] Currently, the WHO oral mucositis scoring scale is focusing on the oral functionality and replying on tube feeding as a cut-off criterion for Grade 3 oral mucositis (Moslemi et al., 2016). However, there are clinical situations where a subject may require tube feeding due to reasons other than severe OM, for instance, due to nausea and dysphagia. The inventors have developed a further “Grade Y” (patients "require nasal/gastric tube feeding with the main causes being nausea and dysphagiaor shortly after surgery”), which is introduced into the OM assessment table in order to separate those subjects who may require tube feeding but are still considered to have an oral mucosa condition of grade 3 or higher, which would exclude them from being recruited. [00137] As used herein, the term “Grade Y” refers to a further and new grading category introduced by the inventors of the present invention in addition to the Oral Mucositis Score of the WHO, which is classified into 5 grades (grades 0-4) based on the changes of patients' oral mucosa and ability to eat. In particular, the WHO scoring defines Grade 4 of OM as ‘Oral alimentation impossible’. “Grade Y” was introduced by the inventors to further stratify the grading system and corresponds to the condition wherein subjects or patients “require nasal/gastric tube feeding with the main causes being nausea and dysphagia or shortly after surgery”. [00138] This additional “Grade Y” allows a subject, who would otherwise be excluded from the trial, to become eligible for inclusion and to receive the investigational drug for the prevention of severe RIOM. For example, as shown for Subject 5 (see, Table 5), the oral mucosa condition has been assigned a Grade 1 according to the RTOG grade guide. Given a RTOG grade of 1, the patient is included in the clinical trial on RIOM. However, since the patient has been relying on tube feeding to avoid vomiting and/or to promote oral surgery wound healing at the time of assessment for clinical trial enrolment, based on the traditional oral intake status grade guide provided by the WHO, CTCAE (i.e., without a grade Y category), the patient would have been assigned a grade 4. Accordingly, being assigned a grade 4, the patient would not have been ineligible to participate in the clinical trial and/or to receive the investigational drug for the prevention of severe RIOM. Evidently, this means that the patient would have been excluded from clinical trial enrolment for the wrong reasons, i.e., simply because tube feeding was required because of oral surgery. [00139] However, by introducing this new Grade Y, the inventors are providing a new category that considers those patients who do require nasal/gastric tube feeding with the main causes being nausea and dysphagia or shortly after surgery. Hence, these subjects are now eligible for assessment and able to be included in the clinical trial. [00140] On the contrary, Subject 6 (see, Table 6) considered to experience severe OM with RTOG grade 3 OM for the lips. The subject relies on tube feeding as grade 3 OM induced significant mouth ulceration and pain. Accordingly, the oral food intake status has been assigned a grade 4, rendering the subject ineligible for clinical trial selection. [00141] Using this new classification, the inventors have developed a new system to categorise oral intake status and to further improve the overly broad definition of Grade 4 as provided by the WHO, CTCAE Grade guide. Using this new Grade Y, the inventors have not only further stratified the grading system but also developed a way to also include those subjects that would otherwise be excluded based on the traditional grade guide, which however, do require nasal/gastric tube feeding with the main causes being nausea and dysphagia.

Table 5. OM Assessment Sheet: OM Highest Grade noted for Subject 5: Grade 1; WHO*:___Y___; RTOG**:___1___; NCI-CTCAE#:___Y___. * - WHO = World Health Organisation; OM Highest Grade noted according to the WHO guidelines; ** - RTOG = Radiation Therapy Oncology Group # - NCI-CTCAE = National Cancer Institute-Common Terminology Criteria for Adverse Events (CTCAE)

Table 6. OM Assessment Sheet: OM Highest Grade noted for Subject 6: Grade 4; WHO*:___4___; RTOG**:___3___; NCI-CTCAE#:___4___. * - WHO = World Health Organisation; OM Highest Grade noted according to the WHO guidelines; ** - RTOG = Radiation Therapy Oncology Group # - NCI-CTCAE = National Cancer Institute-Common Terminology Criteria for Adverse Events (CTCAE)

Example 4. Using delineation of OAR including Extended Oral Cavity, Buccal Mucosa, Lips, Tongue, and Palate as specific radiation exposure measurement sites for selecting eligible subject for RIOM clinical trial. [00142] Apart from assessment of OM status for the eligibility of a subject to be included in the clinical trial, the inventors of the present application have developed a radiation exposure level assessment table to enable a precision prediction and selection of a subject who has high risk to develop severe RIOM (see, Table 7). Using defined inclusion criteria for screening patients for participating in clinical studies on RIOM, the factual radiation dose received on oral mucosa tissue can be recorded and subsequently correlated to the severity levels of oral mucositis secondary to radiation damage. [00143] As previously reported, oral mucosa has a certain tolerability to ionising radiation dose below 10 Gy without resulting in severe RIOM. Clinical experience suggests that dose–area effects may influence mucositis severity. Hence, assessing the radiation dose delivered to certain surface areas of the oral mucosa is necessary to predict and subsequently properly select the subjects, who are at high risk of developing severe RIOM, for inclusion in clinical trials on investigative drugs for the treatment and/or the prevention of severe RIOM. [00144] The consensus guidelines for head and neck OAR delineation based on CT images were defined in 2015, aiming to decrease interobserver variability among clinicians and radiotherapy centres, which also gave distinct definition of OARs including the locations relevant to RIOM such as extended oral cavity, lips, and buccal mucosa (Brouwer et al., 2015). [00145] In the claimed invention, a Radiation Exposure Data Collection Sheet has been developed following the 2015 consensus guideline for OAR delineation to collect the relevant mean radiation dose to be delivered to the specific OAR locations and areas related to RIOM. The subject who has been prescribed to receive radiotherapy for his/her disease treatment will consequently receive radiation exposure on various OAR structures. [00146] Inclusion criteria: Only when the mean radiation dose to be delivered to the RIOM-related OARs (i.e., extended oral cavity, buccal mucosa, and lips) reaches to above 10 Gy, will the subject be likely to experience RIOM. In particular, severe RIOM tends to develop when the radiation exposure is above 30 Gy. Hence, a subject is eligible to be included in the clinical trial on an investigation drug for the prevention of severe RIOM, if the subject is preparing to receive a mean dose of about at least 30 Gy on either the extended oral cavity, or buccal mucosa or lips. [00147] An example Radiation Exposure Data Collection Sheet with the mean radiation dose to the RIOM-related OARs from a subject is shown in Table 7 below. As shown in Table 6, a patient having been assigned a planned mean dose (Gy) of 42.7, 39.4, and 17.3Gy for the extended oral cavity, buccal mucosa, and lips, respectively, will be included in the clinical trial. Table 7: Using delineation of OAR including for selecting eligible subject for RIOM clinical trial. Gy = Grey; PTV = planning target volume. [00148] These data show that a subject can be selected for inclusion in a clinical trial irrespective of the cancer status and solely based on the mean radiation dose planned to the relevant OAR structures. Example 5. Patient Reported Outcome Measure for Oral Mucositis (OM). [00149] In order to further detail radiation-induced oral mucositis severity besides the clinician’s observation, a patient’s report outcome questionnaire is developed after consultation of head and neck cancer patients who have experienced severe RIOM while receiving high dose of radiotherapy on head and neck areas. [00150] The questionnaire is scored using carton facial expression instead of numerical scale according to patients’ preference. The questionnaire is illustrated in Table 8 below: Table 8. Patient Reported Outcome Measure for Oral Mucositis (OM) (Facial Expression Indicators). Please only answer a specific question IF you have mouth sores and circle the appropriate response: [00151] In summary, the inventors of the present application have shown that the OM grading system can be used to assess and grade patients with respect to their likelihood to develop radiation induced inflammatory mucosal lesions and ulcerations in an organ-at-risk (OAR), dermatitis, and/or hair loss. Also, the inventors have shown that the OM grading system can be used to determine radiation induced oral mucositis (RIOM) severity in a subject, when the subject is preparing to receive, or has previously received, a mean radiation dose of about at least 10 Gy to an OAR, and that that based on this assessment patients can be selected for inclusion in a clinical trial, wherein the trial is designed to determine the effectiveness of an investigational compound for preventing or reducing the severity of radiation-induced inflammatory mucosal lesions and ulcerations in an OAR, dermatitis, and/or hair loss. Specifically, the inventors have shown that the OM grading system can be refined by introducing a new grading category (“grade X”). Similarly, the inventors have refined the oral intake status grading system by introducing a new “grade Y” to also select and include those patients for clinical trials who require tube feeding and who may benefit from treatment with the investigative drug. [00152] Those having ordinary skill in the art will appreciate that the disclosure can be modified in ways not specifically described herein.

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Mucositis incidence, severity and associated outcomes in patients with head and neck cancer receiving radiotherapy with or without chemotherapy: a systematic literature review. Radiotherapy and Oncology.66(3): 253-262. 19. Vera-Llonch, M.; Oster, G.; Ford, C. M..; Lu, J.; Sonis, S. (2007). Oral mucositis and outcomes of allogeneic hematopoietic stem-cell transplantation in patients with hematologic malignancies. Support Care Cancer.15(5): 491-496. 20. Vera-Llonch, M.; Oster, G.; Hagiwara, M.; Sonis, S. (2006). Oral mucositis in patients undergoing radiation treatment for head and neck carcinoma. Cancer. 106(2): 329-336. 21. Yuen, A. H. L.; Li, A. K. L.; Mak, P. C. Y.; Leung, H. L.. (2021). Implementation of web-based opensource radiotherapy delineation software (WORDS) in organs at risk contouring training for newly qualified radiotherapists: quantitative comparison with conventional one-to-one coaching approach . BMC Med Educ. 21(564): 1-8. Embodiments of the invention 1. A method of assessing radiation induced oral mucositis (RIOM) severity in a subject, wherein the subject is preparing to receive, or has previously received, a mean radiation dose of about at least 10 grey (Gy) to an organ-at-risk (OAR), wherein the method comprises: (i) determining an oral mucositis (OM) scoring grade (grade 0 to 4) in the subject, wherein the determining comprises recording oral mucositis (OM) scoring parameters for the OAR, wherein the parameters comprise erythema, colour change in mucosa to white or pallor, detachment of epithelium from small ulcerative lesions (sporadic and non-contiguous), white pseudo membrane covering surface, widespread ulcerative lesions over subsites by > 1.5 cm, easy bleeding from ulcerative lesions with contact, spontaneous bleeding from ulcerative lesions, necrosis of ulcerative surface, and mucosa not evaluable according to the Radiation Therapy Oncology Group (RTOG) and NCI-CTCAE; (ii) determining the oral intake status for the subject according to the WHO Common Terminology Criteria for Adverse Events (CTCAE) grade guide (grade 0 to 4); and (iii) determining the grade of OM severity based on the information obtained in steps (i) and (ii), wherein the OM grading system ranges from 0-4; wherein a grade of 0 is indicative of no OM. 2. The method of paragraph 2, wherein the OM scoring grades comprise an additional grade X, wherein grade X corresponds to a condition wherein the mucosa is not evaluable. 3. The method of paragraphs 1 or 2, wherein the method comprises an additional step after step (ii), wherein this step comprises obtaining subject reported information for OM, wherein the information comprises data on mouth pain, speaking difficulty, restriction of speech, eating difficulty, restriction on eating, drinking difficulty, swallowing difficulty, and change in taste. 4. The method according to any one of paragraphs 1-3, wherein oral mucositis (OM) scoring parameters are recorded for extended oral cavity, buccal mucosa, lips, tongue and palate. 5. The method according to any one of paragraphs 1-4, wherein the oral intake grading system comprises an additional grade Y, wherein grade Y is defined as requiring nasal and/or gastric tube feeding with the main causes being nausea and dysgeusia. 6. The method according to any one of paragraphs 1-5, wherein assessing RIOM severity includes determining a factual radiation dose received on oral mucosa tissue relative to severity levels of oral mucositis secondary to radiation damage. 7. A method of diagnosing or aiding in the diagnosis of radiation-induced oral mucositis (RIOM) in a subject, wherein the subject is preparing to receive, or has previously received, a mean radiation dose of about at least 10 grey (Gy) to an OAR, and wherein the method comprises: (a) assessing RIOM severity in the subject according to any one of paragraphs 1-6; (b) diagnosing the patient with RIOM, if the grade is equal to or higher than 1 according to the international consensus grading system for OM. 8. A method of screening for radiation-induced oral mucositis (RIOM) in a subject, wherein the subject is preparing to receive, or has previously received, a mean radiation dose of about at least 10 grey (Gy) to an OAR, and wherein the method comprises: (a) assessing RIOM severity in the subject according to any one of paragraphs 1-6; (b) determining RIOM according to the RTOG grade guide, wherein a grade of 1 or higher, is indicative for RIOM. 9. A method of selecting a subject for inclusion in a clinical trial, wherein the trial is designed to determine the effectiveness of an investigational compound, or pharmaceutical composition, a device, a therapy, and/or a method for preventing, or reducing the severity of, radiation-induced: (a) inflammatory mucosal lesions and ulcerations in an organ-at-risk (OAR), (b) dermatitis, and/or (c) hair loss in the subject; wherein the method of selecting said subject comprises: (i) recording a planning target volume (PTV) radical dose, a PTV elective dose, an organ-at-risk (OAR) volume, and wherein the OAR is extended oral cavity, buccal mucosa and lips, and a mean radiation dose (Gy) planned; and (ii) selecting the subject for inclusion in the clinical trial, if the subject is preparing to receive a mean dose of about at least 30 Gy on at least one of the OAR listed in (i). 10. The method of selecting a subject according to paragraph 7, wherein the method comprises a step of assessing RIOM severity in the subject according to any one of paragraphs 1-6, and wherein the subject is selected for inclusion in the clinical trial, if the RIOM is of grade 2 or lower according to the World Health Organization (WHO) oral mucositis scale/common toxicity criteria, or Radiation Therapy Oncology Group (RTOG) scale, or National Cancer Institute Common Terminology Criteria (NCI CTC), or Common Terminology Criteria for Adverse Events (CTCAE) grading system for oral mucositis (OM). 11. The method according to paragraph 10, wherein the subject is selected for inclusion in the clinical trial, if (i) the highest OM grade for an OAR area examined is a grade 2 or lower according to the RTOG grade guide; or (ii) the highest OM grade for an OAR area examined is a grade 2 or lower according to the RTOG grade guide and one or more of the OAR has been assigned a grade X, optionally where in the oral intake status is a grade 0, 1, 2 or Y. 12. The method according to paragraph 10 or 11, wherein the subject is selected for inclusion in the clinical trial, if the OM grade of all OAR examined is a grade 2 or lower according to the RTOG and the oral intake status is 0, 1, 2 or Y (WHO, CTCAE). 13. The method according to any one of paragraphs 1-12, wherein the subject has previously received or is preparing to receive a mean radiation dose of about at least 10 Gy on the OAR. 14. The method according to any one of paragraphs 1-13, wherein, the mean radiation dose received or planned is between about 10 and 70 Gy. 15. The method according to any one of paragraphs 1-14, wherein the mean radiation dose received or planned is about 10-50 Gy, preferably wherein the mean radiation dose received or planned is about 30 Gy. 16. The method according to paragraphs 9-15, wherein the inflammatory mucosal lesions and ulcerations are radiation-induced oral mucositis (RIOM). 17. The method of any one of paragraphs 1-16, wherein the subject has a benign or malignant medical condition. 18. The method according to paragraph 17, wherein the malignant condition is cancer, optionally wherein the cancer is selected from a list comprising head and neck cancer, breast cancer, cervix cancer, prostate cancer, and eye cancer, melanoma, skin basal cell carcinoma (BCC), neuroblastoma, non-Hodgkin lymphoma (NHL), Brain tumour and neuroblastoma, Various types of cancers and their metastasis cancers. Spinal cord tumours and spine tumours, Leukaemia, Lymphoma and Hodgkin's lymphoma, Melanoma, Chordoma, Ewing's sarcoma, Mesothelioma, Osteosarcoma, Meningioma, Soft tissue sarcomas, Haemangioma, Chondrosarcoma, Adenomas. 19. The method according to paragraph 18, wherein the benign condition is selected from the list comprising benign raised scars (benign keloids), non- cancerous benign tumours, Mesothelioma, Graves ophthalmopathy, or thyroid eye disease, Orbital pseudotumor, Meningioma, Trigeminal neuralgia and fibroelastoma, Acoustic neuroma or schwannomas and Heterotopic bone formation, Arteriovenous malformations, Bone malignancies. 20. The method according to any one of paragraphs 1-19, wherein the subject (i) concurrently receives radiotherapy, chemoradiotherapy, immunotherapy or any other therapy; and/or (ii) has previously been exposed to treatment with chemotherapy, immunotherapy or any other therapy. 21. A method of identifying a subject who would be expected to benefit from prophylaxis against RIOM to prevent interruption of food intake, wherein the subject is expecting to receive, or has previously received, a mean radiation dose of at least about 10 grey (Gy) to an organ-at-risk (OAR), and wherein the method comprises: (i) assessing RIOM severity in the subject according to any one of paragraphs 1-6; (ii) optionally diagnosing the patient with RIOM according to paragraph 6; and (iii) selecting the subject for prophylaxis, if (a) the existing highest grade of OM is equal to or lower than 2; or (b) the predicted highest grade of RIOM is equal to or higher than 3. 22. A method of treating radiation-induced oral mucositis (RIOM) in a subject that has previously been assessed, selected, diagnosed and/or identified according to any of the methods of paragraphs 1 to 21, wherein the method comprises administering to the subject an effective amount of a pharmaceutical composition comprising one or more of the following selected from aloe vera, aminothiol molecules and/or compounds such as amifostine, cysteamine, N-acetylcysteine, PrC-210, PrC-211, and PrC-252, cryotherapy, granulocyte colony stimulating factor (G-CSF), intravenous glutamine, honey, keratinocyte growth factor, laser irradiation, polymyxin/ tobramycin / amphotericin (PTA) antibiotic tablet / paste, sucralfate, supersaturated calcium phosphate, sodium phosphate, natural and homeopathic agents, any molecules directly or indirectly protect cellular damage caused by Reactive Oxygen Species (ROS) such as superoxide dismutase mimetic including but not limited to avasopasem manganese and rucosopasem manganese, any inhibitors of nitric oxide synthases such as linear and cyclic N,S- substituted isothioureas and the derivatives, any vasoconstrictors such as clonidine and salt formats, any reagent having effect on bacterial, microbial environment and/or biofilm, any reagent targeting on fungal infection, any reagent having an effect on modulating immune response, any reagent for preventing and/or reducing an infection, inflammation and/or pain. 23. The method of paragraph 22, wherein the subject receives individualised radiotherapy schedules without increasing toxicity on OAR. 24. A method of predicting mucosal toxicity for an investigational compound or pharmaceutical composition in a subject, and wherein the method comprises determining RIOM scoring in the first week of radiotherapy by assessing radiation- induced oral mucositis (RIOM) severity in the subject according to any of the method of paragraphs 1-6, wherein the RIOM scoring of grade 3 or higher is used as the toxicity monitoring parameter. 25. The method according to paragraphs 10-20, or 22-24, wherein the pharmaceutical composition comprises 0.9 mg/ml to 15 mg/ml L-epinephrine or salts thereof; and a carrier vehicle comprising ethanol and water; wherein the pharmaceutical composition has a molecular oxygen concentration of less than 5% wt/vol; and wherein the pharmaceutical composition has a pH of less than 3.




 
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