Status:
COMPLETED
A Nutritional Intervention to Decrease Breast Density Among Female BRCA (BReast CAncer Susceptibility Gene) Carriers
Lead Sponsor:
Rabin Medical Center
Conditions:
BRCA1 Gene Mutation
BRCA2 Gene Mutation
Eligibility:
FEMALE
18-70 years
Phase:
NA
Brief Summary
The purpose of this study is to determine whether adding DIM supplement will decrease breast density among female BRCA mutation carriers in two years.
Detailed Description
The Research Question: In female BRCA mutation carriers, will adding DIM (100mg\*1/d, a nutritional supplement), decrease breast density in two years? Study design: A single center single arm prospec...
Eligibility Criteria
Inclusion
- Women who carrier the BRCA 1\\2 mutation.
- No history of breast or ovarian malignancy.
- i. Baseline mammographic breast density is more than 10% OR ii. Baseline breast MRI with density or enhancement ≤ 2.
- Age 18-70.
- Absence of any psychological, familial, sociological or geographical situation potentially hampering adherence to the study protocol and follow-up schedule.
- Informed written consent must be signed according to ICH/EU GCP, before subject registration.
Exclusion
- Women who have undergone preventive breast reduction.
- Breast imaging demonstrating a lesion suspected to be cancerous.
- Breast feeding or Pregnancy or planning to get pregnant.
- Known allergy to DIM and its ingredients.
Key Trial Info
Start Date :
November 11 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 10 2018
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT02197000
Start Date
November 11 2014
End Date
October 10 2018
Last Update
November 12 2020
Active Locations (1)
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1
Rabin Medical Center, Beilinson Hospital
Petah Tikva, Israel, 49100