NCT00033345

Indole-3-Carbinol in Preventing Breast Cancer in Nonsmoking Women Who Are at High Risk For Breast Cancer

Multiple Daily Dose Phase I Safety And Pharmacokinetic Clinical Study Of Indole-3-Carbinol

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: University of Kansas Medical Center · Academic / Other
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	Indole-3-carbinol	400 mg pill taken daily
DRUG	Indole-3-carbinol	800 mg pill taken daily
OTHER	Placebo	Placebo pill taken daily during run-in period

Timeline

• Start date: 2002-01-01
• Primary completion: 2008-07-01
• First posted: 2003-01-27
• Last updated: 2016-08-18

Locations

1 site across 1 country: United States