Multiple Daily Dose Phase I Safety And Pharmacokinetic Clinical Study Of Indole-3-Carbinol
- 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
- 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
Primary Purpose: Prevention
Aryeh Hurwitz, MD
University of Kansas
United States: Federal Government
|University of Kansas Medical Center||Kansas City, Kansas 66160-7353|