Melatonin for Prevention of Radiation Induced Oral Mucositis

Hams Hamed Abdelrahman

Status and phase: Completed; Phase 2

Conditions: Oral Mucositis (Ulcerative) Due to Radiation

Treatments: Drug: Oracure gel; Other: Alkamisr sachets; Drug: Miconaz oral gel; Drug: BBC oral spray; Dietary Supplement: Rapid Release Capsules Melatonin, 10 mg

Study type: Interventional

Funder types: Other

Identifiers

NCT03833570

0008839

Details and patient eligibility

About

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

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 25+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Melatonin therapy

Experimental group

Description:

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

Treatment:

Other: Alkamisr sachets

Drug: Oracure gel

Drug: Miconaz oral gel

Drug: BBC oral spray

Dietary Supplement: Rapid Release Capsules Melatonin, 10 mg

Conventional therapy

Active Comparator group

Description:

Conventional therapy (symptomatic treatment) which included: * Miconaz oral gel * BBC oral spray * Oracure gel * Alkamisr sachets Dose: Three times a day for six weeks

Treatment:

Other: Alkamisr sachets

Drug: Oracure gel

Drug: Miconaz oral gel

Drug: BBC oral spray