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COMPLETEDPHASE2

Melatonin for Prevention of Radiation Induced Oral Mucositis

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

NCT03833570•Hams Hamed Abdelrahman

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.

Eligibility

Age

25 - No limit years

Sex

ALL

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.

Locations (1)

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

Alexandria, Egypt

Key Dates

Start Date

January 12, 2018

Primary Completion Date

November 9, 2018

Completion Date

December 1, 2018

Last Updated

June 17, 2019

Enrollment

ACTUAL participants

Conditions

Oral Mucositis (Ulcerative) Due to Radiation

Interventions

Rapid Release Capsules Melatonin, 10 mg

DIETARY_SUPPLEMENT

Miconaz oral gel

DRUG

BBC oral spray

DRUG

Oracure gel

DRUG

Alkamisr sachets

OTHER

A Prospective Study on the Therapeutic Outcomes of Mebo and Tantum Verde in Patients With Oral Mucositis

NCT07186114

Oral Mucositis (Ulcerative) Due to Radiation

View study

COMPLETEDNA

Photobiomodulation to Demonstrate Safety and Reduce the Incidence of Oral Mucositis in Adult Head & Neck Cancer Patients

NCT03972527

Oral Mucositis (Ulcerative)Oral Mucositis (Ulcerative) Due to Radiation+2 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 17, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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Melatonin for Prevention of Radiation Induced Oral Mucositis

Inclusion Criteria

Exclusion Criteria

A Prospective Study on the Therapeutic Outcomes of Mebo and Tantum Verde in Patients With Oral Mucositis

Photobiomodulation to Demonstrate Safety and Reduce the Incidence of Oral Mucositis in Adult Head & Neck Cancer Patients

Dexpanthenol Mouthwash to Treat Oral Mucositis