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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified July 2014 by Rabin Medical Center
Sponsor:
Information provided by (Responsible Party):
Rabin Medical Center
ClinicalTrials.gov Identifier:
NCT02197000
First received: July 20, 2014
Last updated: July 21, 2014
Last verified: July 2014
  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: 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Estrogen profile [ Time Frame: 0, 4, 8, 12, 16 and 24 months following initiation ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Quality of life will be evaluate using the Revised Illness Perception Questionnaire.


Estimated Enrollment: 100
Study Start Date: September 2014
Estimated Study Completion Date: January 2018
Estimated Primary Completion Date: September 2017 (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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Women who carrier the BRCA 1\2 mutation
  • Base line mammographic breast density is more than 10%
  • Age 18-70
  • Absence of any psychological, familial, sociological or geographical situation potentially hampering adherence to the study protocol and follow-up schedule.
  • The patient is willing and able to read, understand and sign the study specific informed consent form.

Exclusion Criteria:

  • Previous breast cancer
  • Women who have undergone preventive breast reduction
  • Entry mammographic breast density less than 10%
  • Entry mammography demonstrating a lesion suspected to be cancerous
  • Pregnancy or planning to get pregnant
  • Known allergy to DIM
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02197000

Contacts
Contact: Rinat Yerushalmi, MD +972(0)39378089 rinat.yerushalmi@gmail.com

Locations
Israel
Rabin Medical Center, Beilinson Hospital Not yet recruiting
Petah-Tikva, Israel, 49100
Contact: R. Ozalvo    +972(0)39378089      
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

No publications provided

Responsible Party: Rabin Medical Center
ClinicalTrials.gov Identifier: NCT02197000     History of Changes
Other Study ID Numbers: 0117-14-RMC
Study First Received: July 20, 2014
Last Updated: July 21, 2014
Health Authority: Israel: Ministry of Health

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

ClinicalTrials.gov processed this record on October 23, 2014