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
Verified date | February 2019 |
Source | Fondazione IRCCS Istituto Nazionale dei Tumori, Milano |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
Status | Completed |
Enrollment | 88 |
Est. completion date | February 23, 2016 |
Est. primary completion date | March 25, 2014 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 60 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Italy | Cristina Ferraris | Milan |
Lead Sponsor | Collaborator |
---|---|
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano |
Italy,
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* Note: There are 19 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Menopause Rating Scale (MRS) | 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. |
24 months | |
Primary | weight gain (kg) | 24 months | ||
Primary | insulin resistance | fasting blood glucose x fasting blood insulin (HOMA-IR) | 24 months | |
Secondary | endometrial thickness | assessed by annual pelvic ultrasound (mm) | 24 months | |
Secondary | breast density | assessed by annual mammography (BI-RADS) | 24 months | |
Secondary | growth of breast cancer cell lines highly expressing estrogen receptors | OD Units | 24 months | |
Secondary | transcript expression of estrogen-regulated genes in breast cancer cell lines highly expressing estrogen receptors | transcript levels | 24 months |
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