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Efficacy of High-Dose Melatonin in Alleviating Radiotherapy-Induced Fatigue in Breast Cancer Patients: A Randomized Phase II Trial
Sponsor: Menoufia University
Summary
To assess the role of High-Dose Melatonin in Alleviating Radiotherapy-Induced Fatigue in Breast Cancer Patients. The primary end point is assessment of fatigue severity . Secondary end points Assessment of skin toxicity to evaluate melatonin's secondary radioprotective benefits
Key Details
Gender
All
Age Range
18 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
51
Start Date
2024-10-02
Completion Date
2026-08-20
Last Updated
2026-10-08
Healthy Volunteers
No
Interventions
Melatonin
for melatonin group (experimental) :Oral administration of 15 mg melatonin 30-60 min before bedtime on Day 1 of radiotherapy and continuing until 1 week post-completion of the final fraction (including the boost)
Placebo
Oral administration of an identical-appearing capsule containing microcrystalline cellulose 30-60 min before bedtime on Day 1 of radiotherapy and continuing until 1 week post-completion of the final fraction (including the boost)
Locations (1)
Menoufia University, Faculty of medicine
Shibīn al Kawm, Menoufia, Egypt