NCT03833570

Melatonin for Prevention of Radiation Induced Oral Mucositis

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Hams Hamed Abdelrahman · Academic / Other
• Sex: All
• Age: 25 Years
• Healthy volunteers: Accepted

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.

Conditions

• Oral Mucositis (Ulcerative) Due to Radiation

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Rapid Release Capsules Melatonin, 10 mg	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.
DRUG	Miconaz oral gel	Antifungal agent
DRUG	BBC oral spray	Topical anesthetics and anti-inflammatory agent
DRUG	Oracure gel	Topical analgesic gel
OTHER	Alkamisr sachets	Sodium bicarbonate mouthwash

Timeline

• Start date: 2018-01-12
• Primary completion: 2018-11-09
• Completion: 2018-12-01
• First posted: 2019-02-07
• Last updated: 2019-06-17

Locations

1 site across 1 country: Egypt