Clinical trial NCT03844685: Red Clover and Lifestyle Changes to Contrast Menopausal Symptoms in Premenopausal Breast Cancer Patients Given Tamoxifen
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Cancer
Lead sponsor: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Sponsor class: OTHER
First posted: 2019-02-18
Enrollment: 88
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, randomized, double-blind clinical trial
Primary purpose: TREATMENT

Brief summary: 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

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Menopause Rating Scale (MRS)
timeFrame: 24 months
measure: weight gain (kg)
timeFrame: 24 months
measure: insulin resistance
timeFrame: 24 months
Secondary outcomes:
measure: endometrial thickness
timeFrame: 24 months
measure: breast density
timeFrame: 24 months
measure: growth of breast cancer cell lines highly expressing estrogen receptors
timeFrame: 24 months
measure: transcript expression of estrogen-regulated genes in breast cancer cell lines highly expressing estrogen receptors
timeFrame: 24 months
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Cristina Ferraris
Study officials:
References:
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