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

The purpose of this study is to determine whether adding DIM supplement will decrease breast density among female BRCA mutation carriers in two years.

Study Overview

• Status: Completed
• Conditions: BRCA1 Gene Mutation; BRCA2 Gene Mutation
• Intervention / Treatment: Dietary supplement: DIM-Avail 100mg

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.

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Petah-Tikva, Israel, 49100
    • Rabin Medical Center, Beilinson Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: 3,3-Diindolylmethane

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Rabin Medical Center
• Investigators: 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

Study record dates

Study Major Dates

• Study Start (Actual): November 11, 2014
• Primary Completion (Actual): October 10, 2018
• Study Completion (Actual): October 10, 2018

Study Registration Dates

• First Submitted: July 20, 2014
• First Submitted That Met QC Criteria: July 21, 2014
• First Posted (Estimate): July 22, 2014

Study Record Updates

• Last Update Posted (Actual): November 12, 2020
• Last Update Submitted That Met QC Criteria: November 9, 2020
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: Breast cancer; BRCA mutation; Breast density; Estrogen metabolism; 3,3-Diindolylmethane
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Antineoplastic Agents; Protective Agents; Anticarcinogenic Agents; 3,3'-diindolylmethane
• Other Study ID Numbers: 0117-14-RMC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO