Red Clover and Lifestyle Changes to Contrast Menopausal Symptoms in Premenopausal Breast Cancer Patients Given Tamoxifen
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|ClinicalTrials.gov Identifier: NCT03844685|
Recruitment Status : Completed
First Posted : February 18, 2019
Last Update Posted : February 20, 2019
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: Promensil Drug: Placebo Oral Tablet||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||88 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Prospective, randomized, double-blind clinical trial|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Masking Description:||Patient and personnel involved in trial masked to treatment vs. placebo|
|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|
|Actual Study Start Date :||July 5, 2012|
|Actual Primary Completion Date :||March 25, 2014|
|Actual Study Completion Date :||February 23, 2016|
Experimental: Treatment group
1 tablet /day of MCE-11 (Promensil) taken orally for 24 months
1 tablet (80 mg) /day of MCE-11 (Promensil) taken orally for 24 months
Placebo Comparator: Placebo group
Placebo tablet (without active principle) given once a day for 24 months
Drug: Placebo Oral Tablet
Placebo tablet (80 mg) (without active principle) given once a day for 24 months
- Menopause Rating Scale (MRS) [ Time Frame: 24 months ]
Full name of questionnaire is "Menopause Rating Scale" ; The total score of the MRS ranges between 0 (asymptomatic) and 44 (highest degree of complaints). the ranges are: 0-4 no/little symptoms, 5-8 mild, 9-15 moderate and 16/16+ severe.
The sub-scale are: Psychological score, (Question N° 4-7), Somatic score (Question N° 1-3; 11), Urogenital score (Question N° 8-10). The subscales are combined in a total MRS score.
- weight gain (kg) [ Time Frame: 24 months ]
- insulin resistance [ Time Frame: 24 months ]fasting blood glucose x fasting blood insulin (HOMA-IR)
- endometrial thickness [ Time Frame: 24 months ]assessed by annual pelvic ultrasound (mm)
- breast density [ Time Frame: 24 months ]assessed by annual mammography (BI-RADS)
- growth of breast cancer cell lines highly expressing estrogen receptors [ Time Frame: 24 months ]OD Units
- transcript expression of estrogen-regulated genes in breast cancer cell lines highly expressing estrogen receptors [ Time Frame: 24 months ]transcript levels
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03844685
|Milan, Italy, 20133|