Indole-3-Carbinol in Preventing Breast Cancer in Nonsmoking Women Who Are at High Risk For Breast Cancer
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.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||Multiple Daily Dose Phase I Safety And Pharmacokinetic Clinical Study Of Indole-3-Carbinol|
|Study Start Date:||January 2002|
|Primary Completion Date:||July 2008 (Final data collection date for primary outcome measure)|
Experimental: High-Risk Breast Cancer
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.
400 mg pill taken daily
Other Name: I3CDrug: Indole-3-carbinol
800 mg pill taken daily
Other Name: I3COther: Placebo
Placebo pill taken daily during run-in period
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00033345
|United States, Kansas|
|University of Kansas Medical Center|
|Kansas City, Kansas, United States, 66160-7320|
|Study Chair:||Aryeh Hurwitz, MD||University of Kansas|