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01-02-2020 | Breast Cancer | Clinical trial

Red clover and lifestyle changes to contrast menopausal symptoms in premenopausal patients with hormone-sensitive breast cancer receiving tamoxifen

Authors: Cristina Ferraris, Barbara Ballestra, Chiara Listorti, Vera Cappelletti, Carolina Reduzzi, Gianfranco P. Scaperrotta, Iolanda Pulice, Eleonora G. A. Ferrari, Secondo Folli, Luigi Mariani, Gabriele Martelli

Published in: Breast Cancer Research and Treatment | Issue 1/2020

Abstract

Purpose

To determine whether a red clover preparation plus dietary intervention administered to premenopausal women with breast cancer (BC), improves menopausal symptoms due to anti-oestrogen treatment, and hence promotes compliance with tamoxifen, prevents weight gain and is safe.

Methods

Surgically-treated premenopausal women with oestrogen receptor (ER) positive disease taking tamoxifen were recruited to a prospective double-blind randomized trial (NCT03844685). The red clover group (N = 42) received one oral tablet/day (Promensil^® Forte) containing 80 mg red clover extract for 24 months. The placebo group (N = 39) received one oral tablet/day without active ingredient. All women were encouraged to follow a Mediterranean-type diet and keep active. Outcomes were Menopausal Rating Score (MRS), body mass index (BMI), waist and hip girth, insulin resistance, and levels of cholesterol, triglycerides, and sex hormones. As safety indicators, endometrial thickness, breast density, and effects of patient serum on ER-positive BC cell lines were investigated.

Results

MRS reduced significantly (p < 0.0001) with no between-group difference (p = 0.69). The red clover group had significantly greater reductions in BMI and waist circumference (p < 0.0001 both cases). HDL cholesterol increased significantly in both groups (p = 0.01). Hormone levels and insulin resistance changed little. Endometrial thickness remained constant (p = 0.93). Breast density decreased significantly in both groups (p < 0.0001). Proliferation and oestrogen-regulated gene expression didn’t differ in cell lines treated with serum from each group.

Conclusions

This is the first trial to assess red clover in BC patients on tamoxifen. The preparation proved safe clinically and in vitro, and was associated with reduced BMI and waist circumference, but the diet-lifestyle intervention probably improved the menopausal symptoms.

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Title: Red clover and lifestyle changes to contrast menopausal symptoms in premenopausal patients with hormone-sensitive breast cancer receiving tamoxifen
Authors: Cristina Ferraris
Barbara Ballestra
Chiara Listorti
Vera Cappelletti
Carolina Reduzzi
Gianfranco P. Scaperrotta
Iolanda Pulice
Eleonora G. A. Ferrari
Secondo Folli
Luigi Mariani
Gabriele Martelli
Publication date: 01-02-2020
Publisher: Springer US
Keywords: Breast Cancer
Breast Cancer
Tamoxifen
Estrogens
Estradiol
Published in: Breast Cancer Research and Treatment / Issue 1/2020
Print ISSN: 0167-6806
Electronic ISSN: 1573-7217
DOI: https://doi.org/10.1007/s10549-020-05534-4

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