Indole-3-Carbinol in Preventing Cancer in Healthy Participants
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|ClinicalTrials.gov Identifier: NCT00100958|
Recruitment Status : Completed
First Posted : January 10, 2005
Last Update Posted : July 24, 2008
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.
|Condition or disease||Intervention/treatment||Phase|
|Unspecified Adult Solid Tumor, Protocol Specific||Drug: indole-3-carbinol||Phase 1|
- 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.
- 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 Type :||Interventional (Clinical Trial)|
|Official Title:||Phase I Ascending Single Dose Pharmacokinetics (PK) and Safety Study of 3,3' Di-Indolymethane (DIM) Nutritional Product|
|Study Start Date :||November 2004|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00100958
|United States, Kansas|
|Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center|
|Kansas City, Kansas, United States, 66160-7357|
|Principal Investigator:||Gregory Reed, PhD||University of Kansas|