Breast Cancer Research and Treatment

, Volume 145, Issue 2, pp 381–388 | Cite as

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

  • Wendy Y. ChenEmail author
  • Anita Giobbie-Hurder
  • Kathryn Gantman
  • Jennifer Savoie
  • Rochelle Scheib
  • Leroy M. Parker
  • Eva S. Schernhammer
Clinical Trial


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.


Breast cancer Melatonin Sleep disturbance Survivorship Clinical trial 



Cognitive behavioral therapy


Center for Epidemiologic Studies-Depression


Dana-Farber Cancer Institute


Estrogen receptor


Insulin-like growth factor


Menopause Specific Quality of Life


Melatonin receptor 1


North Central Cancer Treatment Group


Pittsburgh Sleep Quality Index



We are grateful to the participants of this trial, as well as to the staff at the Dana-Farber Cancer Institute that helped facilitate the trial’s conduct. This study was supported by a grant from the National Cancer Institute (R03 CA123597). The funding source had no role in the design or analysis of the study or in the decision to submit the manuscript for publication.

Conflict of interest

The authors declare that they have no conflict of interest.


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Copyright information

© Springer Science+Business Media New York 2014

Authors and Affiliations

  • Wendy Y. Chen
    • 1
    • 2
    Email author
  • Anita Giobbie-Hurder
    • 3
  • Kathryn Gantman
    • 4
  • Jennifer Savoie
    • 2
  • Rochelle Scheib
    • 2
  • Leroy M. Parker
    • 2
  • Eva S. Schernhammer
    • 1
    • 5
    • 6
  1. 1.Channing Division of Network MedicineBrigham and Women’s Hospital and Harvard Medical SchoolBostonUSA
  2. 2.Department of Medical OncologyDana-Farber Cancer InstituteBostonUSA
  3. 3.Department of Biostatistics & Computational BiologyDana-Farber Cancer InstituteBostonUSA
  4. 4.Mount Auburn HospitalCambridgeUSA
  5. 5.Department of EpidemiologyHarvard School of Public HealthBostonUSA
  6. 6.ACR-ITR & LBI-ACR VIEnna/CEADDPViennaAustria

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