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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
Sponsor:
Information provided by (Responsible Party):
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

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

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: Promensil Drug: Placebo Oral Tablet Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 88 participants
Allocation: Randomized
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
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Treatment group
1 tablet /day of MCE-11 (Promensil) taken orally for 24 months
Drug: Promensil
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




Primary Outcome Measures :
  1. 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.


  2. weight gain (kg) [ Time Frame: 24 months ]
  3. insulin resistance [ Time Frame: 24 months ]
    fasting blood glucose x fasting blood insulin (HOMA-IR)


Secondary Outcome Measures :
  1. endometrial thickness [ Time Frame: 24 months ]
    assessed by annual pelvic ultrasound (mm)

  2. breast density [ Time Frame: 24 months ]
    assessed by annual mammography (BI-RADS)

  3. growth of breast cancer cell lines highly expressing estrogen receptors [ Time Frame: 24 months ]
    OD Units

  4. transcript expression of estrogen-regulated genes in breast cancer cell lines highly expressing estrogen receptors [ Time Frame: 24 months ]
    transcript levels



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

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


Locations
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Italy
Cristina Ferraris
Milan, Italy, 20133
Sponsors and Collaborators
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Publications of Results:

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Responsible Party: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
ClinicalTrials.gov Identifier: NCT03844685     History of Changes
Other Study ID Numbers: INT 101/11
First Posted: February 18, 2019    Key Record Dates
Last Update Posted: February 20, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases