Trial reportBreast cancer research and treatment2014
A randomized, placebo-controlled trial of melatonin on breast cancer survivors: impact on sleep, mood, and hot flashes.
Trial report in Breast cancer research and treatment, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 69 papers, 13 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
69 citing papers in PubMed, 13 syntheses or guidelines pooled it, 125 citations in OpenAlex.
- Exploring the impact of melatonin on cancer-related fatigue: a dose-response meta-analysis with GRADE evidence evaluation.BMC cancer · 2026Pooled it
- Comparative efficacy of interventions for insomnia in cancer patients: a systematic review and network meta-analysis.Sleep & breathing = Schlaf & Atmung · 2025Pooled it
- Proposal for Managing Cancer-Related Insomnia: A Systematic Literature Review of Associated Factors and a Narrative Review of Treatment.Cancer medicine · 2024Pooled it
- Interventions for insomnia in cancer patients and survivors-a comprehensive systematic review and meta-analysis.JNCI cancer spectrum · 2024Pooled it
- Effects of melatonin intake on depression and anxiety in postmenopausal women: a systematic review and meta-analysis of randomised controlled trials.Archives of women's mental health · 2024Pooled it
- Guideline
- Pooled it
- The Therapeutic Effect of Exogenous Melatonin on Depressive Symptoms: A Systematic Review and Meta-Analysis.Frontiers in psychiatry · 2022Pooled it
- Effect of melatonin supplementation on sleep quality: a systematic review and meta-analysis of randomized controlled trials.Journal of neurology · 2022Pooled it
- Sleep Disorders in Cancer-A Systematic Review.International journal of environmental research and public health · 2021Pooled it
- 5th ESO-ESMO international consensus guidelines for advanced breast cancer (ABC 5).Annals of oncology : official journal of the European Society for Medical Oncology · 2020Guideline
- Comparing Interventions for Management of Hot Flashes in Patients With Breast and Prostate Cancer: A Systematic Review With Meta-Analyses.Oncology nursing forum · 2020Pooled it
- Survivorship, Version 2.2017, NCCN Clinical Practice Guidelines in Oncology.Journal of the National Comprehensive Cancer Network : JNCCN · 2017Guideline
- Targeting Side Effects Associated with Androgen Deprivation Therapy Using Melatonin: A Randomized Trial on Hot Flashes and Sexual Health in Prostate Cancer Patients.Asian Pacific journal of cancer prevention : APJCP · 2026Trial
- The effect of preoperative melatonin patches on sleep quality in patients undergoing urological surgery.Revista da Associacao Medica Brasileira (1992) · 2026Trial
- A randomized double-blind placebo-controlled trial of the effectiveness of melatonin on neurocognition and sleep in survivors of childhood cancer.Pediatric blood & cancer · 2022Trial
- Trial
- Effect of Melatonin on Sleep in the Perioperative Period after Breast Cancer Surgery: A Randomized, Double-Blind, Placebo-Controlled Trial.Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine · 2016Trial
- Article
- Guidelines for the Diagnosis and Treatment of Advanced Breast Cancer in China (2024 Edition).Cancer innovation · 2025Article
9 more citing papers are in PubMed but not listed here.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors at 3 institutions in 2 countries.
Funding
Abstract
The purpose is to examine the effects of melatonin supplementation on sleep, mood, and hot flashes in postmenopausal breast cancer survivors. In a randomized, double-blind, placebo-controlled study, 95 postmenopausal women with a prior history of stage 0-III breast cancer, who had completed active cancer treatment (including hormonal therapy) were randomly assigned 1:1 to either 3 mg oral melatonin (n = 48) or placebo daily (n = 47) for 4 months. Sleep, mood, and hot flashes were assessed at baseline and 4 months via self-administered questionnaire using the Pittsburgh Sleep Quality Index (PSQI), Center for Epidemiologic Studies-Depression (CES-D), and the North Central Cancer Treatment Group (NCCTG) hot flash diary, respectively. Eighty-six women (91 %) completed the study and provided pre- and post-questionnaires. At baseline, 52 % of participants reported poor sleep in the month prior to enrollment. Compared to subjects on placebo, subjects randomized to melatonin experienced significantly greater improvements in subjective sleep quality as measured by the PSQI, including domains on sleep quality, daytime dysfunction and total score. For example, the mean change in PSQI score was -0.1 in the placebo group compared to -1.9 in the melatonin group (p < 0.001). There were no significant differences in measures of depression or hot flashes. Sleep disturbances are common among breast cancer survivors, even after completion of active cancer treatment. This is the first randomized placebo-controlled study among breast cancer survivors to demonstrate that melatonin was associated with an improvement in subjective sleep quality, without any significant adverse effects.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.