A Nutritional Intervention to Decrease Breast Density Among Female BRCA Carriers -A Prospective Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Rabin Medical Center
- Enrollment
- 23
- Locations
- 2
- Primary Endpoint
- Changes in breast density compared to baseline
Study Overview
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 prospective interventional study of the use of DIM to decrease risk of breast cancer among female BRCA carriers.
Study population: Subjects will be female carriers of a BRCA mutation and have more than 10% mammographic breast density at baseline.
Intervention: DIM supplement (100mg*1/d).
Study Time line: This will be a 2 years study. At initiation a breast mammography will be performed and eligibility assessed. Follow-up visits will occur every 4 months and quality of life questionnaires as well as adherence to DIM supplementation will be assessed. At the initiation and every 4 months blood and urine samples will be collected for Estrogen profile. At 12 and 24 months a mammography will be performed to verify changes in breast density.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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 ≤
- •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 Criteria
- •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.
Outcomes
Primary Outcomes
Changes in breast density compared to baseline
Time Frame: 0, 12 and 24 months following intiation
The amount of fibroglandular tissue (FGT) and background parenchymal enhancement (BPE) on magnetic resonance imaging (MRI)
Secondary Outcomes
- Estrogen profile(0, 4, 8, 12, 16 and 24 months following initiation)
- The Estronex Profile(0, 12 and 24 months following initiation)
- change in Quality of life(0, 4, 8, 12, 16 and 24 months following initiation)