Completed

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

What is being tested

Rapid Release Capsules Melatonin, 10 mg

+ Miconaz oral gel

+ BBC oral spray

Dietary SupplementDrugOther

Who is being recruted

Stomatognathic Diseases+3

+ Mouth Diseases

+ Pathologic Processes

Over 25 Years

+9 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Prevention Study

Phase 2

Interventional

Study Start: January 2018

See protocol details

Summary

Principal SponsorHams Hamed Abdelrahman

Last updated: January 27, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: January 12, 2018

Actual date on which the first participant was enrolled.

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 TitleThe Effectiveness of Melatonin in Prevention of Radiation-induced Oral Mucositis

NCT03833570

Principal SponsorHams Hamed Abdelrahman

Last updated: January 27, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

40 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Prevention Study

Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 25 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Stomatognathic DiseasesMouth DiseasesPathologic ProcessesStomatitisPathological Conditions, Signs and SymptomsUlcer

Criteria

3 inclusion criteria required to participate

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.

6 exclusion criteria prevent from participating

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.

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

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

Group II

Active Comparator

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

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

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

Alexandria, EgyptOpen Outpatient clinic of Department of Clinical Oncology, Faculty of Medicine, Alexandria University in Google Maps

CompletedOne Study Center