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

NCT01022333 | Unknown Phase 1 DMC

• 1 other identifier: 2009-015-B
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Cancer

Keywords

BRCA1; breast cancer; 3,3'-di-indolylmethane; dietary intervention; estrogen metabolites; mRNA expression; BRCA1 protein; Estrogen

Outcome Measures

Primary Outcomes (1)

• Oral DIM supplementation increases BRCA1 mRNA expression and hence BRCA1 protein in women with a BRCA1 mutation

  6 months

Secondary Outcomes (1)

• Oral DIM supplementation causes favorable estrogen metabolism in women with a BRCA1 mutation

  6 months

Study Arms (3)

DIM group (BRCA1 carriers)

EXPERIMENTAL

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)

No DIM group (BRCA1 carriers)

NO INTERVENTION

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.

General Control Group

NO INTERVENTION

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.

Interventions

Diindolylmethane (DIM) DIETARY_SUPPLEMENT

300 mg per day of DIM for six weeks.

Also known as: Rx Balance BioResponse DIM

DIM group (BRCA1 carriers)

Eligibility Criteria

• Age: 25 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Women's College Hospital: lead
• BioResponse: collaborator

Study Sites (1)

Familial Breast Cancer Research Unit, Women's College Research Institute

Toronto, Ontario, M5G 1N8, Canada

RECRUITING

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

• Steven A Narod, MD

  Women's College Research Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Joanne Kotsopoulos, PhD

CONTACT

416-351-3732; joanne.kotsopoulos@wchospital.ca

Marcia Llacuachaqui, HonBSc

CONTACT

416-351-3768; marcia.llacuachaqui@wchospital.ca

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 26, 2009
• First Posted: December 1, 2009
• Study Start: July 1, 2009
• Primary Completion: July 1, 2010
• Study Completion: December 1, 2010
• Last Updated: December 1, 2009

Record last verified: 2009-11

Locations

CA (1)