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Completed
NCT07865988
Efficacy of High-Dose Melatonin in Alleviating Radiotherapy-Induced Fatigue in Breast Cancer Patients: A Randomized Phase II Trial
Conditions: Breast Cancer, Radiotherapy Induced Fatigue
Sex: All
Ages: 18 Years – 70 Years
Healthy volunteers: No
Phase: PHASE2, PHASE3
Enrollment: 51
Sponsor: Menoufia University
Location: Menoufia University, Faculty of medicine Shibīn al Kawm Menoufia
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
Eligibility Criteria
Inclusion Criteria:
* • Female patients, aged 18-75 years, with histologically confirmed Breast Cancer (Stage II-III).
* Scheduled for adjuvant radiotherapy including a tumor bed boost and/or Regional Lymph Node Irradiation (LNI).
* Baseline Fatigue score \> 4 on the Piper Fatigue Scale .
* ECOG Performance Status of 0-1
Exclusion Criteria:
* • History of autoimmune diseases or chronic inflammatory conditions.
* Current use of exogenous melatonin or systemic corticosteroids.
* Metastatic disease (Stage IV).
Source: ClinicalTrials.gov (NCT07865988). StuddyBuddy aggregates publicly available trial information.
