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

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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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Abbreviations

CBT:

Cognitive behavioral therapy

CES-D:

Center for Epidemiologic Studies-Depression

DFCI:

Dana-Farber Cancer Institute

ER:

Estrogen receptor

IGF:

Insulin-like growth factor

MENQOL:

Menopause Specific Quality of Life

MT1:

Melatonin receptor 1

NCCTG:

North Central Cancer Treatment Group

PSQI:

Pittsburgh Sleep Quality Index

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Acknowledgments

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.

Author information

Authors and Affiliations

  1. Channing Division of Network Medicine, Brigham and Women’s Hospital and Harvard Medical School, Boston, MA, USA

    Wendy Y. Chen & Eva S. Schernhammer

  2. Department of Medical Oncology, Dana-Farber Cancer Institute, 450 Brookline Avenue, Boston, MA, 02215, USA

    Wendy Y. Chen, Jennifer Savoie, Rochelle Scheib & Leroy M. Parker

  3. Department of Biostatistics & Computational Biology, Dana-Farber Cancer Institute, Boston, MA, USA

    Anita Giobbie-Hurder

  4. Mount Auburn Hospital, Cambridge, MA, USA

    Kathryn Gantman

  5. Department of Epidemiology, Harvard School of Public Health, Boston, MA, USA

    Eva S. Schernhammer

  6. ACR-ITR & LBI-ACR VIEnna/CEADDP, Vienna, Austria

    Eva S. Schernhammer

Authors
  1. Wendy Y. Chen
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  2. Anita Giobbie-Hurder
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  3. Kathryn Gantman
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  4. Jennifer Savoie
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  5. Rochelle Scheib
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  7. Eva S. Schernhammer
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Correspondence to Wendy Y. Chen.

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Chen, W.Y., Giobbie-Hurder, A., Gantman, K. et al. A randomized, placebo-controlled trial of melatonin on breast cancer survivors: impact on sleep, mood, and hot flashes. Breast Cancer Res Treat 145, 381–388 (2014). https://doi.org/10.1007/s10549-014-2944-4

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  • DOI: https://doi.org/10.1007/s10549-014-2944-4

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