Melatonin for Prevention of Radiation Induced Oral Mucositis

Study Overview
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Brief Summary
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The main aim of this study was to evaluate the effectiveness of melatonin in prevention of radiation induced oral mucositis clinically and biochemically.

Detailed Description
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The study was designed as randomized, controlled, clinical trial. patients who were undergoing chemoradiation were divided into two groups: Group I: was given conventional treatment. Group II: was given melatonin therapy in combination with the conventional treatment. All patients were clinically evaluated at the start the radiotherapy, three weeks and six weeks later for pain and oral mucositis severity. in addition, the total antioxidant capacity of the melatonin was evaluated at the start of the radiotherapy and six weeks later.

Official Title
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The Effectiveness of Melatonin in Prevention of Radiation-induced Oral Mucositis

Conditions
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Oral Mucositis (Ulcerative) Due to Radiation

Intervention / Treatment
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* Dietary Supplement: Rapid Release Capsules Melatonin, 10 mg
* Drug: Miconaz oral gel
* Drug: BBC oral spray
* Drug: Oracure gel
* Other: Alkamisr sachets


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who are going to receive radiotherapy as a treatment of head and neck cancer either as postoperative (adjuvant) therapy or definitive therapy. Patients whose radiotherapy treatment planned dose is between 60-70 Gy. Patients who had received chemotherapy prior to radiotherapy or are going to receive chemotherapy in concomitant to radiotherapy. Exclusion Criteria: Patients under Anticoagulants such as warfarin, heparin, or aspirin. Patients under Fluvoxamine (Luvox) and Nifedipine medications. Patients whose radiotherapy treatment planned dose is lower than 60 Gy. Pregnant and lactating women. Patients suffering from any uncontrolled systemic diseases (such as diabetes, cardiovascular, liver disorder, renal dysfunction) Patients with findings of any physical or mental abnormality which would interfere with or be affected by the study procedure.

Ages Eligible for Study
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Minimum Age: 25 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Melatonin therapy<br>Rapid Release Capsules Melatonin, 10 mg in combination with the symptomatic treatment Symptomatic treatment which included: Miconaz oral gel BBC oral spray Oracure gel Alkamisr sachets Melatonin capsules dose: Two tablets,30 minutes before sleeping once daily for six weeks Symptomatic treatment dose: Three times a day for six weeks | Dietary Supplement: Rapid Release Capsules Melatonin, 10 mg<br>* Melatonin is a dietary supplement which is naturally produced in the body and closely involved in the natural sleep cycle. recently topical and systemic melatonin supplements. have been proposed as a new therapeutic modality for oral mucositis due to its anti-cancer, anti-inflammatory, and anti-oxidant effects.<br>Drug: Miconaz oral gel<br>* Antifungal agent<br>Drug: BBC oral spray<br>* Topical anesthetics and anti-inflammatory agent<br>Drug: Oracure gel<br>* Topical analgesic gel<br>Other: Alkamisr sachets<br>* Sodium bicarbonate mouthwash<br>|
| Active Comparator: Conventional therapy<br>Conventional therapy (symptomatic treatment) which included: Miconaz oral gel BBC oral spray Oracure gel Alkamisr sachets Dose: Three times a day for six weeks | Drug: Miconaz oral gel<br>* Antifungal agent<br>Drug: BBC oral spray<br>* Topical anesthetics and anti-inflammatory agent<br>Drug: Oracure gel<br>* Topical analgesic gel<br>Other: Alkamisr sachets<br>* Sodium bicarbonate mouthwash<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in severity of oral mucositis at different time points along the study | Oral mucositis will be evaluated by the World Health Organization (WHO) scale which record the extent and severity of oral mucositis at the third and sixth week after the first radiotherapy session. This scale combines both subjective and objective measures of oral mucositis. World Health Organization (WHO) scale for oral mucositis: Grade 0 = No oral mucositis Grade 1 = Erythema and Soreness Grade 2 = Ulcers, able to eat solids Grade 3 = Ulcers, requires liquid diet (due to mucositis) Grade 4 = Ulcers, alimentation not possible (due to mucositis) | up to 3 and 6 weeks | 
| Changes in the total antioxidant capacity (TAC) in saliva at different time points along the study | TAC is an index that measures total capacity of antioxidants in biological fluids using Colorimetric Method. it can evaluate the antioxidant response against the free radicals produced by radiotherapy. Normal reference values for TAC in saliva: 0.3-1 mM/L Higher values than normal range indicate higher level of TAC Changes in the total antioxidant capacity were evaluated at the first day of radiotherapy session (baseline) and six weeks later | Baseline (day 0) and up to 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain and discomfort severity at different time points along the study: Numeric Rating Scale | Discomfort and pain severity were reported by each patient using Numeric Rating Scale (NRS) at the third and sixth week after the first radiotherapy session. The NRS was calibrated from 0 to 10 with ranges tagged as; No pain (NRS 0) Mild pain (NRS 1-3) Moderate pain (NRS 4-7) Unbearable pain (NRS 8-10) | up to 3 and 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Melatonin