Research paper

A randomized, placebo-controlled trial of melatonin on breast cancer survivors: impact on sleep, mood, and hot flashes

Breast Cancer Research and Treatment

Apr 2014

DOI: 10.1007/s10549-014-2944-4

Citations: 118

Influential: 6

Interventional (Human) Studies

Study answer

What this study found

Melatonin improved subjective sleep quality versus placebo over 4 months. The PSQI total score improved more in the melatonin group than in the placebo group (change -1.9 vs -0.1; overall p=0.001), with the main benefit reflected in fewer sleep problems and less daytime dysfunction. There were no significant differences for depressive symptoms (CES-D p=0.66) or hot flashes, including total hot flash score (p=0.19) and mean number/day (p=0.28). The regimen was well tolerated, with no grade 3/4 toxicities; common grade 1/2 adverse effects included headache, fatigue, and bad dreams.

Study & population: Randomized, double-blind, placebo-controlled trial conducted at Dana-Farber Cancer Institute in Boston, USA.
Intervention: Melatonin 3 mg orally nightly at 9 p.m.
Key limitation: The intervention was evaluated in a single-center study with a modest active-arm sample size and a 4-month follow-up, which limits precision and long-term inference.

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Original abstract

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