We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study is currently recruiting participants.
Verified October 2017 by Rabin Medical Center
Sponsor:
ClinicalTrials.gov Identifier:
NCT02197000
First Posted: July 22, 2014
Last Update Posted: October 17, 2017
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.
Information provided by (Responsible Party):
Rabin Medical Center
  Purpose
The purpose of this study is to determine whether adding DIM supplement will decrease breast density among female BRCA mutation carriers in two years.

Condition Intervention
BRCA1 Gene Mutation BRCA2 Gene Mutation Dietary Supplement: DIM-Avail 100mg

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Nutritional Intervention to Decrease Breast Density Among Female BRCA Carriers -A Prospective Clinical Trial

Resource links provided by NLM:


Further study details as provided by Rabin Medical Center:

Primary Outcome Measures:
  • Changes in breast density compared to baseline [ Time Frame: 0, 12 and 24 months following intiation ]

Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 36
Study Start Date: September 2014
Estimated Study Completion Date: September 2018
Estimated Primary Completion Date: September 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 3,3-Diindolylmethane

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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02197000


Contacts
Contact: Rinat Yerushalmi, MD +972(0)39376556 rinat.yerushalmi@gmail.com
Contact: Rachel Ozalvo, B.sc, MBA +972(0)39376556 oz.rachel.o@gmail.com

Locations
Israel
Rabin Medical Center, Beilinson Hospital Recruiting
Petah-Tikva, Israel, 49100
Contact: Rachel Ozalvo    +972(0)39376553    racheloz@clalit.org.il   
Principal Investigator: David Margel, M.D, PhD         
Principal Investigator: Rinat Yerushalmi, MD         
Sponsors and Collaborators
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
  More Information

Responsible Party: Rabin Medical Center
ClinicalTrials.gov Identifier: NCT02197000     History of Changes
Other Study ID Numbers: 0117-14-RMC
First Submitted: July 20, 2014
First Posted: July 22, 2014
Last Update Posted: October 17, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Rabin Medical Center:
BRCA mutation
Breast cancer
Estrogen metabolism
3,3-Diindolylmethane
Breast density