Breast Cancer Clinical Trial
Official title:
RED CLOVER EXTRACT (PROMENSIL) AND LIFESTYLE CHANGES TO CONTRAST MENOPAUSAL SYMPTOMS IN PREMENOPAUSAL WOMEN WITH HORMONE-SENSITIVE BREAST CANCER RECEIVING ADJUVANT ANTI-ESTROGEN THERAPY
A prospective double-blind randomized trial of red clover extract (Promensil) vs placebo in surgically-treated premenopausal women with estrogen receptor-positive breast cancer taking tamoxifen
Premenopausal women with ER-positive breast cancer treated by surgery and receiving
postoperative tamoxifen with or without LHRH analogues, who may have received pre or
postoperative chemotherapy, or immunotherapy (for HER2-positive disease), are recruited to a
double-blind randomized clinical trial, to receive either a dry extract of red clover
(Promensil) as one tablet/day orally containing 80 mg isoflavones (treatment group), or one
oral tablet/day without active principle (placebo group) for 24 months. All patients receive
a diet-lifestyle intervention involving meetings with a dietician (physician) scheduled once
a month for the first 6 months, and every 3 months thereafter. The dietician encourages
patients to adhere to a macronutrient-balanced, low glycaemic load Mediterranean-type diet
with personalized recommendations to increase intakes of unrefined cereals, pulses,
vegetables, unrefined vegetable fats (e.g. olive oil, nuts, oil-containing seeds), and fish,
and reduce intake of high-glycaemic-index foods and saturated animal fats. Patients are also
encouraged to undertake regular physical activity. Outcomes are Menopausal Rating Score
(MRS), body mass index (BMI), waist and hip girth, insulin resistance, and levels of
cholesterol, triglycerides, and sex hormones.
The safety of the red clover preparation is assessed by pelvic ultrasound and mammograms for
endometrial thickness and breast density, and by evaluation of the effects of the serum from
treated and placebo patients on ER-positive BC cell lines.
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