Indole-3-Carbinol in Preventing Breast Cancer in Nonsmoking Women Who Are at High Risk For Breast Cancer
- Registration Number
- NCT00033345
- Lead Sponsor
- University of Kansas Medical Center
- Brief Summary
RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. Indole-3-carbinol may be effective in preventing breast cancer.
PURPOSE: Phase I trial to study the effectiveness of indole-3-carbinol in preventing breast cancer in nonsmoking women who are at high risk for breast cancer.
- Detailed Description
OBJECTIVES:
* Determine the safety and tolerability of indole-3-carbinol for the prevention of breast cancer in non-smoking women at high risk for breast cancer.
* Determine the pharmacokinetics of this drug in these participants.
* Determine the effect of this drug on metabolites of estrogen in urine of these participants.
* Determine other additional effects of this drug on selected indicators of drug metabolism and reproductive and hormonal function in these participants.
* Assess any possible antineoplastic activity of this drug in these participants.
* Determine the quality of life of participants receiving this drug.
OUTLINE: This is a single-blind study.
Participants ingest study compound twice daily on weeks 1-12 or 1-16. Study compound is dispensed on weeks 1, 5, and 9. At times, study compound is oral placebo, and at other times, oral indole-3-carbinol.
Quality of life is assessed at baseline and then every 4 weeks during study therapy.
PROJECTED ACCRUAL: A total of 18 participants will be accrued for this study within 9 months.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 17
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description High-Risk Breast Cancer Placebo All subjects first went through a 4-week placebo run-in period. Next, subjects took Indole-3-carbinol 400mg daily for 4 weeks followed by a 4-week period of Indole-3-carbinol 800mg daily. High-Risk Breast Cancer Indole-3-carbinol All subjects first went through a 4-week placebo run-in period. Next, subjects took Indole-3-carbinol 400mg daily for 4 weeks followed by a 4-week period of Indole-3-carbinol 800mg daily.
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States