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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02197000
Recruitment Status : Recruiting
First Posted : July 22, 2014
Last Update Posted : October 17, 2017
Information provided by (Responsible Party):
Rabin Medical Center

July 20, 2014
July 22, 2014
October 17, 2017
September 2014
September 2018   (Final data collection date for primary outcome measure)
Changes in breast density compared to baseline [ Time Frame: 0, 12 and 24 months following intiation ]
Same as current
Complete list of historical versions of study NCT02197000 on Archive Site
  • Estrogen profile [ Time Frame: 0, 4, 8, 12, 16 and 24 months following initiation ]
    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 ]
    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 ]
    Quality of life will be evaluate using the Revised Illness Perception Questionnaire.
Same as current
Not Provided
Not Provided
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.

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.

Not Applicable
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
  • BRCA1 Gene Mutation
  • BRCA2 Gene Mutation
Dietary Supplement: DIM-Avail 100mg
DIM 100 mg*1 daily for 2 years
Other Name: 3,3-Diindolylmethane
Experimental: DIM-Avail 100mg
women will receive DIM 100mg*1/d, a nutritional supplement for 24 months.
Intervention: Dietary Supplement: DIM-Avail 100mg
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
September 2018
September 2018   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: Female
18 Years to 70 Years   (Adult, Older Adult)
Contact: Rinat Yerushalmi, MD +972(0)39376556
Contact: Rachel Ozalvo,, MBA +972(0)39376556
Not Provided
Plan to Share IPD: Undecided
Rabin Medical Center
Rabin Medical Center
Not Provided
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
Rabin Medical Center
October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP