The Effectiveness of Melatonin in Prevention of Radiation-induced Oral Mucositis
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Changes in severity of oral mucositis at different time points along the study
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 25 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
Melatonin therapy
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
Intervention: Miconaz oral gel (Drug)
Melatonin therapy
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
Intervention: Rapid Release Capsules Melatonin, 10 mg (Dietary Supplement)
Melatonin therapy
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
Intervention: BBC oral spray (Drug)
Melatonin therapy
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
Intervention: Oracure gel (Drug)
Melatonin therapy
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
Intervention: Alkamisr sachets (Other)
Conventional therapy
Conventional therapy (symptomatic treatment) which included:
- Miconaz oral gel
- BBC oral spray
- Oracure gel
- Alkamisr sachets
Dose: Three times a day for six weeks
Intervention: Miconaz oral gel (Drug)
Conventional therapy
Conventional therapy (symptomatic treatment) which included:
- Miconaz oral gel
- BBC oral spray
- Oracure gel
- Alkamisr sachets
Dose: Three times a day for six weeks
Intervention: BBC oral spray (Drug)
Conventional therapy
Conventional therapy (symptomatic treatment) which included:
- Miconaz oral gel
- BBC oral spray
- Oracure gel
- Alkamisr sachets
Dose: Three times a day for six weeks
Intervention: Oracure gel (Drug)
Conventional therapy
Conventional therapy (symptomatic treatment) which included:
- Miconaz oral gel
- BBC oral spray
- Oracure gel
- Alkamisr sachets
Dose: Three times a day for six weeks
Intervention: Alkamisr sachets (Other)
Outcomes
Primary Outcomes
Changes in severity of oral mucositis at different time points along the study
Time Frame: 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
Time Frame: 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 Outcomes
- Pain and discomfort severity at different time points along the study: Numeric Rating Scale(up to 3 and 6 weeks)
Investigators
Hams Hamed Abdelrahman
Instructor of Dental Public Health
Alexandria University