A Nutritional Intervention to Decrease Breast Density Among Female BRCA (BReast CAncer Susceptibility Gene) Carriers
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||A Nutritional Intervention to Decrease Breast Density Among Female BRCA Carriers -A Prospective Clinical Trial|
- Changes in breast density compared to baseline [ Time Frame: 0, 12 and 24 months following intiation ] [ Designated as safety issue: No ]
- Estrogen profile [ Time Frame: 0, 4, 8, 12, 16 and 24 months following initiation ] [ Designated as safety issue: No ]changes in TSH (Thyroid Stimulating Hormone), FSH (Follicle Stimulating Hormone), LH (Luteinizing Hormone), Estrogen, Prolactin, Progesterone and Testosterone compare to baseline
- The Estronex Profile [ Time Frame: 0, 12 and 24 months following initiation ] [ Designated as safety issue: No ]changes in the 2, 4, and 16 alpha- hydroxyderivative of estrone and the 2 and 4 methoxyestrone compare to baseline
- Quality of life [ Time Frame: 0, 4, 8, 12, 16 and 24 months following initiation ] [ Designated as safety issue: No ]Quality of life will be evaluate using the Revised Illness Perception Questionnaire.
|Study Start Date:||September 2014|
|Estimated Study Completion Date:||January 2018|
|Estimated Primary Completion Date:||September 2017 (Final data collection date for primary outcome measure)|
Experimental: DIM-Avail 100mg
women will receive DIM 100mg*1/d, a nutritional supplement for 24 months.
Dietary Supplement: DIM-Avail 100mg
DIM 100 mg*1 daily for 2 years
Other Name: 3,3-Diindolylmethane
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.
Primary Endpoint: A decrease of more than 10% in breast density compared to baseline, following DIM supplementation intervention among female BRCA carriers.
Study impact: Decrease in mammographic breast density was shown to be a good marker for lower risk of breast cancer. This study has the potential to dramatically impact the management of female BRCA carriers. If we prove that by adding a food supplement breast density is decreased, we will change standard of care in these woman. In addition, the urine and blood samples collected during the study will be used for future translational research on the pathogenesis of breast cancer.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02197000
|Contact: Rinat Yerushalmi, MD||+972(0)firstname.lastname@example.org|
|Contact: Rachel Ozalvo, B.sc, MBA||+972(0)email@example.com|
|Rabin Medical Center, Beilinson Hospital||Recruiting|
|Petah-Tikva, Israel, 49100|
|Contact: Rachel Ozalvo +972(0)39376553 firstname.lastname@example.org|
|Principal Investigator: David Margel, M.D, PhD|
|Principal Investigator: Rinat Yerushalmi, MD|
|Principal Investigator:||David Margel, MD, PhD||Rabin Medical Center, Beilinson campus, Petah-Tikva, Israel|
|Principal Investigator:||Rinat Yerushalmi, MD||Rabin Medical Center, Beilinson Campus, Petah-Tikva, Israel|