The Potential for Oral Diindolylmethane (DIM) Supplementation to Increase the Production of the BRCA1 Protein in BRCA1 Mutation Carriers

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2009 by Women's College Hospital.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
BioResponse
Information provided by:
Women's College Hospital
ClinicalTrials.gov Identifier:
NCT01022333
First received: November 26, 2009
Last updated: November 30, 2009
Last verified: November 2009
  Purpose

Women with a BRCA1 mutation face a lifetime risk of breast cancer of approximately 70% and a lifetime risk of ovarian cancer of approximately 40%. A number of potential anti-cancer nutrients have been proposed, however, it is important that diet supplements be evaluated prior to general recommendation.

The risk of breast and ovarian cancer in carriers of a BRCA1 mutation might be lowered by some nutritional supplements. For example, green tea, broccoli and vitamin D are of potential interest. One dietary supplement that is thought to have potential for BRCA1 carriers is diindolylmethane (DIM), which is an active ingredient in broccoli and other green vegetables. DIM - is found in vegetables like broccoli and is available as a supplement in health food stores. The investigators think that DIM may increase the production of the normal copy of BRCA1 and offset the effect of the mutation.

The purpose of this study is to determine that there is a potential for oral DIM supplementation to result in the increased production of the BRCA1 protein in BRCA1 mutation carriers. The results of the study will also serve as an evaluation of the current use and success of preventive strategies for BRCA1 mutation carriers.


Condition Intervention Phase
Breast Cancer
Dietary Supplement: Diindolylmethane (DIM)
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: The Potential for Oral DIM Supplementation to Increase the Production of the BRCA1 Protein in BRCA1 Mutation Carriers

Resource links provided by NLM:


Further study details as provided by Women's College Hospital:

Primary Outcome Measures:
  • Oral DIM supplementation increases BRCA1 mRNA expression and hence BRCA1 protein in women with a BRCA1 mutation [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Oral DIM supplementation causes favorable estrogen metabolism in women with a BRCA1 mutation [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 300
Study Start Date: July 2009
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: DIM group (BRCA1 carriers)
This group will have up to 100 women who are carriers of a BRCA1 deleterious mutation. To ensure safety, women in this group will not be able to participate in the study if they are under medications with warfarin, theophylline, or anticonvulsants; or if they are pregnant, breast-feeding or planning to become pregnant within 6 months of the research project. Women in this group will receive 300 mg per day of Rx Balance BioResponse DIM for six weeks. Supplements will be given free of charge. A blood sample (20cc) and a urine sample (20cc) will be collected from these women during two clinic visits; the second visit will be during the six weeks of DIM supplementation (4-6 weeks after the first clinic visit).
Dietary Supplement: Diindolylmethane (DIM)
300 mg per day of DIM for six weeks.
Other Name: Rx Balance BioResponse DIM
No Intervention: No DIM group (BRCA1 carriers)
This group will have up to a 100 women who are carriers of a BRCA1 deleterious mutation. This group will not receive DIM. Women that choose not to take DIM will be in this group. A blood sample (20cc) and a urine sample (20cc) will be collected from these women during two clinic visits; the second visit will be 4-6 weeks after the first clinic visit.
No Intervention: General Control Group
This group will have up to 100 women who do not carry a BRCA1 mutation but who come from BRCA1 carrier family (a family with at least one individual that has tested positive for a BRCA1 mutation). A control subject is considered negative for a BRCA1 mutation if she has been confirmed by direct DNA sequencing to not be a carrier of this gene. A blood sample (20cc) and a urine sample (20cc) will be collected from these women at a single clinic visit.

  Eligibility

Ages Eligible for Study:   25 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Carriers of a mutation in the BRCA1 gene
  • Non-carriers of a mutation in the BRCA1 gene who come from a family with a BRCA1 mutation (a family in which at least one individual has tested positive for a BRCA1 mutation)
  • Can participate after being free of DIM supplementation for one month

Exclusion Criteria:

  • Have a personal history of cancer
  • Currently pregnant or breast-feeding
  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: NCT01022333

Contacts
Contact: Joanne Kotsopoulos, PhD 416-351-3732 ext 2126 joanne.kotsopoulos@wchospital.ca
Contact: Marcia Llacuachaqui, HonBSc 416-351-3768 marcia.llacuachaqui@wchospital.ca

Locations
Canada, Ontario
Familial Breast Cancer Research Unit, Women's College Research Institute Recruiting
Toronto, Ontario, Canada, M5G 1N8
Sponsors and Collaborators
Women's College Hospital
BioResponse
Investigators
Principal Investigator: Steven A Narod, MD Women's College Research Institute
  More Information

No publications provided

Responsible Party: Dr. Steven A. Narod, MD, Familial Breast Cancer Research Unit, Women's College Research Institute
ClinicalTrials.gov Identifier: NCT01022333     History of Changes
Other Study ID Numbers: 2009-015-B
Study First Received: November 26, 2009
Last Updated: November 30, 2009
Health Authority: Canada: Ethics Review Committee
Canada: Health Canada

Keywords provided by Women's College Hospital:
BRCA1
breast cancer
3,3'-di-indolylmethane
dietary intervention
estrogen metabolites
mRNA expression
BRCA1 protein
Estrogen

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on August 21, 2014