Abstract
We examined compliance with and the effects of melatonin supplementation on breast cancer biomarkers (estradiol, insulin-like growth factor I (IGF-1), insulin-like growth factor–binding protein 3 (IGFBP-3), and the IGF-1/IGFBP-3 ratio) in postmenopausal breast cancer survivors. In a double-blind, placebo-controlled study, postmenopausal women with a prior history of stages 0-III breast cancer who had completed active cancer treatment (including hormonal therapy) were randomly assigned to either 3 mg oral melatonin (n = 48) or placebo daily for 4 months. Plasma samples were collected at baseline and after the completion of the intervention. The primary endpoints were compliance and change in estradiol and IGF-1/IGFBP-3 levels. Ninety-five women were randomized (48 to melatonin and 47 to placebo). Eighty-six women (91%) completed the study and provided pre- and postintervention bloods. Melatonin was well tolerated without any grade 3/4 toxicity and compliance was high (89.5%). Overall, among postmenopausal women with a prior history of breast cancer, a 4-month course of 3 mg melatonin daily did not influence circulating estradiol, IGF-1, or IGFBP-3 levels. Compliance was comparable between the two groups. Short-term melatonin treatment did not influence the estradiol and IGF-1/IGBBP-3 levels. Effects of longer courses of melatonin among premenopausal women are unknown. Low baseline estradiol levels in our study population may have hindered the ability to detect any further estradiol-lowering effects of melatonin.
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Acknowledgments
This study was supported by a grant from the National Institutes of Cancer, USA (grant No R03 CA123597 “A Pilot Trial of Oral Melatonin Supplementation in Breast Cancer Survivors,” PI Schernhammer). Because in the United States melatonin is sold as a dietary supplement and not as a drug and the endpoints were biomarkers, no trial registration number was assigned to this NIH-funded study. The funding source had no role in the design or analysis of the study or in the decision to submit the manuscript for publication. 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.
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None of the authors has a conflict of interest to report.
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Schernhammer, E.S., Giobbie-Hurder, A., Gantman, K. et al. A randomized controlled trial of oral melatonin supplementation and breast cancer biomarkers. Cancer Causes Control 23, 609–616 (2012). https://doi.org/10.1007/s10552-012-9927-8
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DOI: https://doi.org/10.1007/s10552-012-9927-8