A randomised double-blind controlled trial of oral soy supplements versus placebo for treatment of menopausal symptoms in patients with early breast cancer
Abstract
Menopausal symptoms are a major survivorship issue for patients treated for breast cancer. There are increasing concerns over the use of hormone replacement therapy (HRT) in this setting and a growing consumer interest in "natural" therapies. It had been suggested that soy phyto-oestrogens might be beneficial in the treatment of menopausal symptoms. Seventy-two patients with a histologically confirmed pre-existing diagnosis of breast cancer who were having menopausal symptoms were randomised between 12 weeks of treatment with soy capsules or placebo. Quality of life and menopausal symptom scores were assessed at baseline, 4, 8 and 12 weeks. There was no statistical difference in menopausal symptom scores or quality of life between the two arms of the study.
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Four cohort studies and three RCTs reported no significant differences in treatment outcomes or rates of adverse effects associated with soy use among women receiving tamoxifen therapy.
“Four cohort studies [100,103,106,112] and three RCTs [128,130,131] reported no significant differences with respect to treatment outcomes or rates of adverse effects associated with use of soy among women who were receiving tamoxifen therapy.”
From Soy, Red Clover, and Isoflavones and Breast Cancer: A Systematic Review (2013) · cites this paper as [128]
The most common adverse event associated with soy consumption was mild to moderate gastrointestinal discomfort, usually occurring with comparable frequency in soy and placebo groups.
“The most common adverse event associated with soy consumption was mild to moderate gastrointestinal discomfort, but this usually occurred with comparable frequency in both the soy and the placebo groups [128,130,131,136,142,147,150]; only in one study was there considerable difference in the frequency of GI upset, 47% in the soy group compared to 22% in the control group [130].”
From Soy, Red Clover, and Isoflavones and Breast Cancer: A Systematic Review (2013) · cites this paper as [128]
The effect of soy on hot flashes in breast cancer patients is not clear.
“The effect of soy on hot flashes in breast cancer patients is not clear.”
From Soy, Red Clover, and Isoflavones and Breast Cancer: A Systematic Review (2013) · cites this paper as [128]
RCTs noted some improvements in hot flashes over time, but not in comparison to placebo.
“RCTs noted some improvements over time, but not in comparison to placebo [127-131].”
From Soy, Red Clover, and Isoflavones and Breast Cancer: A Systematic Review (2013) · cites this paper as [128]
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Treatment of symptoms of the menopause: an Endocrine Society Clinical Practice Guideline
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Soy, Red Clover, and Isoflavones and Breast Cancer: A Systematic Review
Fritz, H., Seely, D., Flower, G., Skidmore, B., Fernandes, R., Vadeboncoeur, S., Kennedy, D., Cooley, K., Wong, R., Sagar, S., et al. (2013) · PLoS ONE · doi:10.1371/journal.pone.0081968 · Cited by 188 · see citing works
- Authors
- MacGregor, C. A., Canney, P. A., Patterson, G., McDonald, R., & Paul, J.
- Affiliations
- Beatson West of Scotland Cancer Centre (GB)
- University of Stirling (GB)
- NHS Ayrshire and Arran (GB)
- Corresponding author
- Canney, P.A.
- ORCID
- Paul, J.
- Venue
- European Journal of Cancer
- Publisher
- Elsevier BV
- Published
- 2005-03
- Volume
- 41
- Issue
- 5
- Pages
- 708-714
- ISSN
- 0959-8049 (ISSN-L)
- OpenAlex
- W2028400867
- Cited by
- 107
- References
- 2
- Citations by year
- 2025: 2 · 2024: 1 · 2023: 3 · 2022: 2 · 2021: 2 · 2020: 3 · 2019: 1 · 2018: 3 · 2017: 4 · 2016: 4 · 2015: 8 · 2014: 5 · 2013: 6 · 2012: 2
- FWCI
- 7.70
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- European Journal of Cancer (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Pathology and Forensic Medicine › Phytoestrogen effects and research
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Menopause: Health Impacts and Treatments
- Health Sciences › Medicine › Oncology › Cancer survivorship and care
- Keywords
- menopausal symptoms, soy phytoestrogens, early breast cancer, breast cancer survivors, quality of life, hormone replacement therapy, natural medicine
- MeSH terms
- Adult, Aged, Breast Neoplasms, Capsules, Double-Blind Method, Nonprescription Drugs, Female, Humans, Isoflavones, Menopause, Middle Aged, Quality of Life, Hot Flashes, Soybean Proteins, Phytoestrogens
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