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

BRCA1 Gene Mutation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02197000
• Other study ID #: 0117-14-RMC
• Status: Completed
• Phase: N/A
• Start date: November 11, 2014
• Est. completion date: October 10, 2018

Study information

• Verified date: October 2017
• Source: Rabin Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: October 10, 2018
• Est. primary completion date: October 10, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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 = 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 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.

Related Conditions & MeSH terms

• BRCA1 Gene Mutation
• BRCA2 Gene Mutation

Intervention

Dietary Supplement:
• DIM-Avail 100mg
DIM 100 mg*1 daily for 2 years

Locations

Country	Name	City	State
Israel	Rabin Medical Center, Beilinson Hospital	Petah-Tikva

Sponsors (1)

Lead Sponsor	Collaborator
Rabin Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in breast density compared to baseline	The amount of fibroglandular tissue (FGT) and background parenchymal enhancement (BPE) on magnetic resonance imaging (MRI)	0, 12 and 24 months following intiation
Secondary	Estrogen profile	changes in TSH (Thyroid Stimulating Hormone), FSH (Follicle Stimulating Hormone), LH (Luteinizing Hormone), Estrogen, Prolactin, Progesterone and Testosterone compare to baseline	0, 4, 8, 12, 16 and 24 months following initiation
Secondary	The Estronex Profile	changes in the 2, 4, and 16 alpha- hydroxyderivative of estrone and the 2 and 4 methoxyestrone compare to baseline	0, 12 and 24 months following initiation
Secondary	change in Quality of life	Quality of life will be evaluate using the Revised Illness Perception Questionnaire.	0, 4, 8, 12, 16 and 24 months following initiation