Effects of melatonin on physical fatigue and other symptoms in patients with advanced cancer receiving palliative care: A double‐blind placebo‐controlled crossover trial

Study answer

What this study found

Melatonin 20 mg nightly did not improve physical fatigue or any other measured symptom or quality-of-life outcome compared with placebo. In the pooled analysis, the difference in change in physical fatigue favored placebo by 2.8 points on a 0 to 100 scale, and the ITT estimate for physical fatigue was not significant (mean difference in change 22.1, 95% CI 29.1 to 4.9; P=.56). No significant differences were seen for fatigue, insomnia, loss of appetite, pain, emotional function, overall quality of life, or the other exploratory endpoints. The authors concluded that melatonin did not relieve…

Study & population

This was a double-blind, placebo-controlled crossover trial conducted in adults with histologically confirmed stage IV cancer receiving palliative care and reporting significant fatigue.

Intervention

Melatonin (N-acetyl-5-methoxytryptamine; MLT) was given orally at 20 mg nightly, taken about 1 hour before sleep for 1 week, in a double-blind crossover design versus identical placebo capsules.

Key limitation

The trial was small and had substantial attrition: 72 patients were randomized, 50 completed the intervention, and 44 were complete compliers.

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Original abstract