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

NCT02197000 | Completed DMC

• 1 other identifier: 0117-14-RMC
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

BRCA1 Gene Mutation; BRCA2 Gene Mutation

Keywords

BRCA mutation; Breast cancer; Estrogen metabolism; 3,3-Diindolylmethane; Breast density

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

Study Arms (1)

DIM-Avail 100mg

EXPERIMENTAL

women will receive DIM 100mg\*1/d, a nutritional supplement for 24 months.

Dietary Supplement: DIM-Avail 100mg

Interventions

DIM-Avail 100mg DIETARY_SUPPLEMENT

DIM 100 mg\*1 daily for 2 years

Also known as: 3,3-Diindolylmethane

DIM-Avail 100mg

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rabin Medical Center: lead

Study Sites (1)

Rabin Medical Center, Beilinson Hospital

Petah Tikva, 49100, Israel

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

3,3'-diindolylmethane

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2014
• First Posted: July 22, 2014
• Study Start: November 11, 2014
• Primary Completion: October 10, 2018
• Study Completion: October 10, 2018
• Last Updated: November 12, 2020

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)