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Evaluation of soy phytoestrogens for the treatment of hot flashes in breast cancer survivors: A North Central Cancer Treatment Group Trial.
J Clin Oncol. 2000 Mar; 18(5):1068-74.JC

Abstract

PURPOSE

Hot flashes represent a significant clinical problem for some breast cancer survivors. Safe, effective treatment is needed for this prominent clinical problem. Although it has been shown that estrogen or progesterone replacement therapy can alleviate this problem, there are continued safety concerns regarding the use of hormonal therapies in these women. Based on anecdotal information, we hypothesized that soy-derived phytoestrogens, weak estrogen-like substances in the soybean that demonstrate estrogen agonist and/or antagonist effects when they bind to estrogen receptors, could alleviate hot flashes. This current trial was designed to investigate this hypothesis.

PATIENTS AND METHODS

This double-blind clinical trial involved breast cancer survivors with substantial hot flashes. After randomization, patients underwent a 1-week baseline period with no therapy. This was followed by 4 weeks of either soy tablets or placebo. The patients then crossed over to the opposite arm in a double-blind manner for the last 4 weeks. Patients completed a daily questionnaire documenting hot flash frequency, intensity, and perceived side effects.

RESULTS

Of the 177 women who were randomized and started the study substance, 155 (88%) provided useable data over the first 5 weeks; 149 provided usable data over the entire 9 weeks. There was no suggestion that the soy product was more effective in reducing hot flashes than the placebo. At study completion, patients preferred the soy product 33% of the time, the placebo 37% of the time, and neither substance 31% of the time. No toxicity was observed.

CONCLUSION

The soy product did not alleviate hot flashes in breast cancer survivors.

Authors+Show Affiliations

Mayo Clinic and Mayo Foundation, Rochester, USA.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Journal Article
Randomized Controlled Trial
Research Support, U.S. Gov't, P.H.S.

Language

eng

PubMed ID

10694559

Citation

Quella, S K., et al. "Evaluation of Soy Phytoestrogens for the Treatment of Hot Flashes in Breast Cancer Survivors: a North Central Cancer Treatment Group Trial." Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology, vol. 18, no. 5, 2000, pp. 1068-74.
Quella SK, Loprinzi CL, Barton DL, et al. Evaluation of soy phytoestrogens for the treatment of hot flashes in breast cancer survivors: A North Central Cancer Treatment Group Trial. J Clin Oncol. 2000;18(5):1068-74.
Quella, S. K., Loprinzi, C. L., Barton, D. L., Knost, J. A., Sloan, J. A., LaVasseur, B. I., Swan, D., Krupp, K. R., Miller, K. D., & Novotny, P. J. (2000). Evaluation of soy phytoestrogens for the treatment of hot flashes in breast cancer survivors: A North Central Cancer Treatment Group Trial. Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology, 18(5), 1068-74.
Quella SK, et al. Evaluation of Soy Phytoestrogens for the Treatment of Hot Flashes in Breast Cancer Survivors: a North Central Cancer Treatment Group Trial. J Clin Oncol. 2000;18(5):1068-74. PubMed PMID: 10694559.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Evaluation of soy phytoestrogens for the treatment of hot flashes in breast cancer survivors: A North Central Cancer Treatment Group Trial. AU - Quella,S K, AU - Loprinzi,C L, AU - Barton,D L, AU - Knost,J A, AU - Sloan,J A, AU - LaVasseur,B I, AU - Swan,D, AU - Krupp,K R, AU - Miller,K D, AU - Novotny,P J, PY - 2000/3/1/pubmed PY - 2000/4/1/medline PY - 2000/3/1/entrez SP - 1068 EP - 74 JF - Journal of clinical oncology : official journal of the American Society of Clinical Oncology JO - J Clin Oncol VL - 18 IS - 5 N2 - PURPOSE: Hot flashes represent a significant clinical problem for some breast cancer survivors. Safe, effective treatment is needed for this prominent clinical problem. Although it has been shown that estrogen or progesterone replacement therapy can alleviate this problem, there are continued safety concerns regarding the use of hormonal therapies in these women. Based on anecdotal information, we hypothesized that soy-derived phytoestrogens, weak estrogen-like substances in the soybean that demonstrate estrogen agonist and/or antagonist effects when they bind to estrogen receptors, could alleviate hot flashes. This current trial was designed to investigate this hypothesis. PATIENTS AND METHODS: This double-blind clinical trial involved breast cancer survivors with substantial hot flashes. After randomization, patients underwent a 1-week baseline period with no therapy. This was followed by 4 weeks of either soy tablets or placebo. The patients then crossed over to the opposite arm in a double-blind manner for the last 4 weeks. Patients completed a daily questionnaire documenting hot flash frequency, intensity, and perceived side effects. RESULTS: Of the 177 women who were randomized and started the study substance, 155 (88%) provided useable data over the first 5 weeks; 149 provided usable data over the entire 9 weeks. There was no suggestion that the soy product was more effective in reducing hot flashes than the placebo. At study completion, patients preferred the soy product 33% of the time, the placebo 37% of the time, and neither substance 31% of the time. No toxicity was observed. CONCLUSION: The soy product did not alleviate hot flashes in breast cancer survivors. SN - 0732-183X UR - https://www.unboundmedicine.com/medline/citation/10694559/Evaluation_of_soy_phytoestrogens_for_the_treatment_of_hot_flashes_in_breast_cancer_survivors:_A_North_Central_Cancer_Treatment_Group_Trial_ L2 - https://ascopubs.org/doi/10.1200/JCO.2000.18.5.1068?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub=pubmed DB - PRIME DP - Unbound Medicine ER -