Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 12:09 AM
Ignite Modification Date:
2025-12-25 @ 12:09 AM
NCT ID:
NCT00100958
Brief Summary:
RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming, growing, or coming back. The use of indole-3-carbinol may prevent cancer.
PURPOSE: This randomized phase I trial is studying the side effects and best dose of indole-3-carbinol and to see how well it works compared to placebo in preventing cancer in healthy participants.
Detailed Description:
OBJECTIVES:
Primary
* Determine the maximum tolerated dose of indole-3-carbinol in healthy participants.
* Determine the safety and tolerability of this drug in these participants.
* Determine the pharmacokinetics of this drug in these participants.
Secondary
* Determine the effects of this drug on selected markers of sexual function in these participants.
* Determine the effects of this drug on markers of susceptibility to cancer in these participants.
OUTLINE: This is a randomized, double-blind, placebo-controlled, dose-escalation study. Participants at each dose level are randomized to 1 of 2 treatment arms.
* Arm I: Participants receive a single dose of oral indole-3-carbinol on day 1.
* Arm II: Participants receive a single dose of oral placebo on day 1. Cohorts of 3 participants receive escalating doses of indole-3-carbinol until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 1 of 3 participants experiences dose-limiting toxicity. An additional cohort of 3 participants is treated at the MTD.
Participants are followed on days 2, 3, and 6.
PROJECTED ACCRUAL: A total of 24 participants (18 in arm I and 6 in arm II) will be accrued for this study.
Study:
NCT00100958
Study Brief:
Protocol Section:
NCT00100958