NCT02197000

A Nutritional Intervention to Decrease Breast Density Among Female BRCA (BReast CAncer Susceptibility Gene) Carriers

A Nutritional Intervention to Decrease Breast Density Among Female BRCA Carriers -A Prospective Clinical Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: Rabin Medical Center · Academic / Other
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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. 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.

Conditions

• BRCA1 Gene Mutation
• BRCA2 Gene Mutation

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	DIM-Avail 100mg	DIM 100 mg\*1 daily for 2 years

Timeline

• Start date: 2014-11-11
• Primary completion: 2018-10-10
• Completion: 2018-10-10
• First posted: 2014-07-22
• Last updated: 2020-11-12

Locations

1 site across 1 country: Israel