Red Clover and Lifestyle Changes to Contrast Menopausal Symptoms in Premenopausal Breast Cancer Patients Given Tamoxifen

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Status and phase: Completed; Phase 2

Conditions: Breast Cancer

Treatments: Drug: Promensil; Drug: Placebo Oral Tablet

Study type: Interventional

Funder types: Other

Identifiers

NCT03844685

INT 101/11

Details and patient eligibility

About

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

Full description

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.

Enrollment: 88 patients

Sex: Female

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histologically confirmed operable ER-positive breast cancer
• Can be ductal carcinoma in situ (DCIS)
• Absence of locoregional relapse or distant metastasis
• Normal ovarian function
• Menopause Rating Score > or equal to 8
• Signed informed consent to participate

Exclusion criteria

• Menopause Rating Score <8
• Menopausal at diagnosis or at surgery
• Previous malignancies other than in situ cervical carcinoma or non-melanoma skin cancer
• Breast cancer recurrence
• Metastatic breast cancer
• Non-epithelial breast cancer at histological examination
• In situ lobular breast cancer
• Participation in other randomized clinical trials that could interfere with current study
• Living distant from center and unable to attend for check-ups and meetings.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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88 participants in 2 patient groups, including a placebo group

Treatment group

Experimental group

Description:

1 tablet /day of MCE-11 (Promensil) taken orally for 24 months

Treatment:

Drug: Promensil

Placebo group

Placebo Comparator group

Description:

Placebo tablet (without active principle) given once a day for 24 months

Treatment:

Drug: Placebo Oral Tablet