Melatonin for Prevention of Radiation Induced Oral Mucositis

Hams Hamed Abdelrahman40 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Oral Mucositis (Ulcerative) Due to Radiation

Interventions

Rapid Release Capsules Melatonin, 10 mgDIETARY_SUPPLEMENT

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.

Miconaz oral gelDRUG

Antifungal agent

BBC oral sprayDRUG

Topical anesthetics and anti-inflammatory agent

Eligibility

Sex: ALLMin age: 25 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Outpatient clinic of Department of Clinical Oncology, Faculty of Medicine, Alexandria University

Alexandria, Egypt

Outcomes

Primary Outcomes

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)

Time frame: 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

Time frame: Baseline (day 0) and up to 6 weeks

Secondary Outcomes

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)

Time frame: up to 3 and 6 weeks

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.