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Efficacy of melatonin supplementation for sleep quality, depression, and fatigue in patients with breast cancer: A systematic review and meta-analysis

Melisha Koirala, A. Pandit

Journal of Clinical Oncology, 2026

568 participants

Abstract

55

Background:

Breast cancer patients frequently experience a cluster of debilitating symptoms, including sleep disturbances, depression, and cancer-related fatigue, which persist during and after treatment. Melatonin, an endogenous hormone regulating circadian rhythms with antioxidant properties, has been proposed as a supportive therapy. However, clinical trials have yielded inconsistent findings regarding its symptomatic benefits. This meta-analysis aims to evaluate the efficacy of melatonin compared to placebo in improving sleep quality, depressive symptoms, and fatigue in breast cancer patients.

Methods:

A systematic review and meta-analysis of randomized controlled trials (RCTs) was conducted. Eligible studies compared oral melatonin supplementation with placebo in patients with breast cancer. Primary outcomes included sleep quality (measured by the Pittsburgh Sleep Quality Index [PSQI]), depression, and fatigue. Data were pooled using a random-effects model in Review Manager (RevMan) due to anticipated heterogeneity. Effect sizes were reported as Mean Differences (MD) for sleep quality and Standardized Mean Differences (SMD) for depression and fatigue, with 95% Confidence Intervals (CI). Heterogeneity was quantified using the I

2

statistic.

Results:

Seven RCTs involving a total of 568 patients were included in the pooled analysis. For sleep quality, analysis of three trials (N=186) showed no statistically significant improvement with melatonin compared to placebo (MD…

How strong is the evidence?

Evidence Hub reads this as a meta-analysis, done in people. Its evidence level is 1 of 5 (Highest · pooled evidence). Pooled evidence from several studies sits at the top of the evidence pyramid. Reported size: 568 participants or records.

How the five levels of evidence work. The level is assigned automatically from the abstract and can be wrong, so check the paper.

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