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
Recruitment status was Recruiting
Sponsor:
Women's College Hospital
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
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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
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 June 17, 2013