A Phase 2/3 interventional study of Melatonin and Placebo in Breast Cancer and Radiotherapy Induced Fatigue, sponsored by Menoufia University. Completed at 1 site in Egypt. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-10-13.
Sponsored by Menoufia University · Phase 2/3, Interventional, and Supportive care
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
Radiotherapy triggers severe fatigue (affecting up to 90% of patients) by generating damaging reactive species (ROS/RNS) and disrupting systemic inflammatory/circadian balance.Melatonin acts as a potent antioxidant via a "scavenger cascade"-crossing membranes and neutralizing free radicals-while resynchronizing flattened diurnal cortisol/circadian rhythms.High doses of Doses of Melatonin during radiotherapy may improve sleep quality and lower clinical fatigue scores.
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This study's enrollment of 51 is below the median of 72 across 9,494 interventional studies indexed under Breast Neoplasms.
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Female patients, aged 18-70 years, with histologically confirmed Breast Cancer (Stage II-III).
Exclusion Criteria:
History of autoimmune diseases or chronic inflammatory conditions.
Patients will be assigned to receive 15 mg of melatonin orally once daily, 30-60 minutes before bedtime, beginning on Day 1 of radiotherapy and continuing until 1 week after completion of the final radiotherapy fraction, including the boost.
Drug: Melatonin
Participants will receive an identical-appearing placebo capsule containing microcrystalline cellulose orally once daily, 30-60 minutes before bedtime, beginning on Day 1 of radiotherapy and continuing until 1 week after completion of the final radiotherapy fraction, including the boost.
Drug: Placebo
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)
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)
Assessment of Change in Fatigue Severity: Measured via the Piper Fatigue Scale (PFS)
Assessment of Change in Fatigue Severity: Fatigue severity will be assessed using the Revised Piper Fatigue Scale (PFS-R), a 22-item self-reported measure of cancer-related fatigue. The total score ranges from 0 to 10, with higher scores indicating greater fatigue severity and therefore a worse outcome.
Time frame: During and 4 weeks post-radiotherapy
Assessment of skin toxicity using the RTOG grading scale to evaluate melatonin's secondary radioprotective benefits
Assessment of Skin Toxicity: Acute radiation-induced skin toxicity will be assessed using the Radiation Therapy Oncology Group (RTOG) acute radiation morbidity grading scale. Skin toxicity is graded from 0 to 4, where Grade 0 indicates no change from baseline and Grade 4 indicates the most severe toxicity, including ulceration, hemorrhage, or necrosis. Higher grades indicate greater skin toxicity and therefore a worse outcome.
Time frame: During and three months post-radiotherapy
Plan to share: Yes — Investigators of this study agreed to share IPD for free with any other investigators with the following conditions: Sharing the data will be after publishing the primary results Other studies using our data should submit our names as sub-investigators when publishing their results
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Melatonin