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

Primary Purpose

Breast Cancer

Status
Unknown status
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
Diindolylmethane (DIM)
Sponsored by
Women's College Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Breast Cancer focused on measuring BRCA1, breast cancer, 3,3'-di-indolylmethane, dietary intervention, estrogen metabolites, mRNA expression, BRCA1 protein, Estrogen

Eligibility Criteria

25 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Familial Breast Cancer Research Unit, Women's College Research InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

No Intervention

No Intervention

Arm Label

DIM group (BRCA1 carriers)

No DIM group (BRCA1 carriers)

General Control Group

Arm Description

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).

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
November 26, 2009
Last Updated
November 30, 2009
Sponsor
Women's College Hospital
Collaborators
BioResponse
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1. Study Identification

Unique Protocol Identification Number
NCT01022333
Brief Title
The Potential for Oral Diindolylmethane (DIM) Supplementation to Increase the Production of the BRCA1 Protein in BRCA1 Mutation Carriers
Official Title
The Potential for Oral DIM Supplementation to Increase the Production of the BRCA1 Protein in BRCA1 Mutation Carriers
Study Type
Interventional

2. Study Status

Record Verification Date
November 2009
Overall Recruitment Status
Unknown status
Study Start Date
July 2009 (undefined)
Primary Completion Date
July 2010 (Anticipated)
Study Completion Date
December 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Women's College Hospital
Collaborators
BioResponse

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
BRCA1, breast cancer, 3,3'-di-indolylmethane, dietary intervention, estrogen metabolites, mRNA expression, BRCA1 protein, Estrogen

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
DIM group (BRCA1 carriers)
Arm Type
Experimental
Arm Description
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).
Arm Title
No DIM group (BRCA1 carriers)
Arm Type
No Intervention
Arm Description
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.
Arm Title
General Control Group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Diindolylmethane (DIM)
Other Intervention Name(s)
Rx Balance BioResponse DIM
Intervention Description
300 mg per day of DIM for six weeks.
Primary Outcome Measure Information:
Title
Oral DIM supplementation increases BRCA1 mRNA expression and hence BRCA1 protein in women with a BRCA1 mutation
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Oral DIM supplementation causes favorable estrogen metabolism in women with a BRCA1 mutation
Time Frame
6 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Joanne Kotsopoulos, PhD
Phone
416-351-3732
Ext
2126
Email
joanne.kotsopoulos@wchospital.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Marcia Llacuachaqui, HonBSc
Phone
416-351-3768
Email
marcia.llacuachaqui@wchospital.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven A Narod, MD
Organizational Affiliation
Women's College Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Familial Breast Cancer Research Unit, Women's College Research Institute
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1N8
Country
Canada
Individual Site Status
Recruiting

12. IPD Sharing Statement

Learn more about this trial

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

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