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

2014-07-24 14:34:13 | BioPortfolio

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.

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.

Study Design

Primary Purpose: Prevention

Conditions

Breast Cancer

Intervention

indole-3-carbinol

Location

University of Kansas Medical Center
Kansas City
Kansas
United States
66160-7320

Status

Completed

Source

National Cancer Institute (NCI)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-24T14:34:13-0400

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