The Potential for Oral Diindolylmethane (DIM) Supplementation to Increase the Production of the BRCA1 Protein in BRCA1 Mutation Carriers
NCT ID: NCT01022333
Last Updated: 2009-12-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1
300 participants
INTERVENTIONAL
2009-07-31
2010-12-31
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
BASIC_SCIENCE
NONE
Study Groups
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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).
Diindolylmethane (DIM)
300 mg per day of DIM for six weeks.
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 interventions assigned to this group
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.
No interventions assigned to this group
Interventions
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Diindolylmethane (DIM)
300 mg per day of DIM for six weeks.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Currently pregnant or breast-feeding
25 Years
45 Years
FEMALE
Yes
Sponsors
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BioResponse
INDUSTRY
Women's College Hospital
OTHER
Responsible Party
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Familial Breast Cancer Research Unit, Women's College Research Institute
Principal Investigators
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Steven A Narod, MD
Role: PRINCIPAL_INVESTIGATOR
Women's College Research Institute
Locations
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Familial Breast Cancer Research Unit, Women's College Research Institute
Toronto, Ontario, Canada
Countries
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Central Contacts
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Other Identifiers
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2009-015-B
Identifier Type: -
Identifier Source: org_study_id