Basic Trial Information
Trial Description
Summary
Eligibility Criteria
Trial Contact Information
| Phase | Type | Status | Age | Sponsor | Protocol IDs |
|---|---|---|---|---|---|
| Phase I | Biomarker/Laboratory analysis, Prevention | Active | 25 to 45 | Other | 2009-015-B NCT01022333 |
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.
Eligibility 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
Trial Lead Organizations/Sponsors
Women's College Hospital
BioResponse| Steven A Narod, MD |  | Principal Investigator |
| Joanne Kotsopoulos, PhD | | Ph: 416-351-3732 Ext.2126 |
| Email: joanne.kotsopoulos@wchospital.ca | ||
Trial Sites
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| Canada | |||
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| Ontario | |||
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| Toronto | |||
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| Women's College Research Institute | |||
Link to the current ClinicalTrials.gov record.
NLM Identifer NCT01022333
Information obtained from ClinicalTrials.gov on December 14, 2011
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