Melatonin for Prevention of Radiation Induced Oral Mucositis

Phase 2

Completed

• Conditions: Oral Mucositis (Ulcerative) Due to Radiation
• Interventions: Dietary Supplement: Rapid Release Capsules Melatonin, 10 mg; Drug: BBC oral spray; Drug: Miconaz oral gel; Drug: Oracure gel; Other: Alkamisr sachets

• Registration Number: NCT03833570
• Lead Sponsor: Hams Hamed Abdelrahman

Brief Summary

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

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.

Study Timeline

• Study Start: 2018-01-12
• Primary Completion: 2018-11-09
• Study Completion: 2018-12-01
• Study First Submitted: 2019-02-03
• Study First Submitted QC: 2019-02-06
• Study First Posted: 2019-02-07
• Status Verified: 2019-06
• Last Update Submitted: 2019-06-13
• Last Update Posted: 2019-06-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional therapy	BBC oral spray	Conventional therapy (symptomatic treatment) which included: * Miconaz oral gel * BBC oral spray * Oracure gel * Alkamisr sachets Dose: Three times a day for six weeks
Melatonin therapy	Rapid Release Capsules Melatonin, 10 mg	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
Melatonin therapy	Miconaz oral gel	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
Melatonin therapy	BBC oral spray	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
Melatonin therapy	Oracure gel	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
Melatonin therapy	Alkamisr sachets	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
Conventional therapy	Miconaz oral gel	Conventional therapy (symptomatic treatment) which included: * Miconaz oral gel * BBC oral spray * Oracure gel * Alkamisr sachets Dose: Three times a day for six weeks
Conventional therapy	Oracure gel	Conventional therapy (symptomatic treatment) which included: * Miconaz oral gel * BBC oral spray * Oracure gel * Alkamisr sachets Dose: Three times a day for six weeks
Conventional therapy	Alkamisr sachets	Conventional therapy (symptomatic treatment) which included: * Miconaz oral gel * BBC oral spray * Oracure gel * Alkamisr sachets Dose: Three times a day for six weeks

Primary Outcome Measures

Name	Time	Method
Changes in severity of oral mucositis at different time points along the study	up to 3 and 6 weeks	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)
Changes in the total antioxidant capacity (TAC) in saliva at different time points along the study	Baseline (day 0) and up to 6 weeks	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

Secondary Outcome Measures

Name	Time	Method
Pain and discomfort severity at different time points along the study: Numeric Rating Scale	up to 3 and 6 weeks	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)

Trial Locations

Locations (1)

Outpatient clinic of Department of Clinical Oncology, Faculty of Medicine, Alexandria University; 🇪🇬 Alexandria, Egypt