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

Information source: Women's College Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Breast Cancer

Intervention: Diindolylmethane (DIM) (Dietary Supplement)

Phase: Phase 1

Status: Recruiting

Sponsored by: Women's College Hospital

Official(s) and/or principal investigator(s):
Steven A Narod, MD, Principal Investigator, Affiliation: Women's College Research Institute

Overall contact:
Joanne Kotsopoulos, PhD, Phone: 416-351-3732, Ext: 2126, Email: joanne.kotsopoulos@wchospital.ca

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.

Clinical Details

Official title: The Potential for Oral DIM Supplementation to Increase the Production of the BRCA1 Protein in BRCA1 Mutation Carriers

Study design: Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Primary outcome: Oral DIM supplementation increases BRCA1 mRNA expression and hence BRCA1 protein in women with a BRCA1 mutation

Secondary outcome: Oral DIM supplementation causes favorable estrogen metabolism in women with a BRCA1 mutation

Eligibility

Minimum age: 25 Years. Maximum age: 45 Years. Gender(s): Female.

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

Locations and Contacts

Joanne Kotsopoulos, PhD, Phone: 416-351-3732, Ext: 2126, Email: joanne.kotsopoulos@wchospital.ca

Familial Breast Cancer Research Unit, Women's College Research Institute, Toronto, Ontario M5G 1N8, Canada; Recruiting
Additional Information

Starting date: July 2009
Last updated: November 30, 2009

Page last updated: August 23, 2015

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