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Sponsors and Collaborators: |
University of Kansas National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00392652 |
RATIONALE: Chemoprevention is the use of certain drugs or substances to keep cancer from forming, growing, or coming back. The use of diindolylmethane may keep cancer from forming. Collecting and storing samples of blood and urine from healthy volunteers to study in the laboratory may help doctors learn more about the way a person's body handles the drug.
PURPOSE: This randomized phase I trial is studying the side effects and best dose of diindolylmethane in healthy volunteers.
Condition | Intervention | Phase |
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Unspecified Adult Solid Tumor, Protocol Specific |
Drug: oral microencapsulated diindolylmethane Procedure: pharmacological study |
Phase I |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double-Blind |
Official Title: | Phase 1 Multiple-Dose Safety, Pharmacokinetic, and Drug Interaction Clinical Study of Nutritional-Grade, Absorption-Enhanced DIM (BR-DIM) |
Estimated Enrollment: | 14 |
Study Start Date: | November 2006 |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a randomized, double-blind study. Participants are stratified according to gender. Participants are randomized to 1 of 2 intervention arms.
Blood and urine are collected periodically for pharmacokinetic profiles of BR-DIM™ and probe drugs.
After completion of study intervention, participants are followed at 1 week.
PROJECTED ACCRUAL: A total of 14 participants will be accrued for this study.
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
No strict vegetarians or consumption of > 3 medium servings (½ cup each) of cruciferous vegetables per week
No serious drug allergies or other serious intolerance or allergies
PRIOR CONCURRENT THERAPY:
No concurrent regular medications or hormones
United States, Kansas | |
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center | Recruiting |
Kansas City, Kansas, United States, 66160-7357 | |
Contact: Gregory Reed, PhD 913-588-7513 |
Principal Investigator: | Gregory Reed, PhD | University of Kansas |
Study ID Numbers: | CDR0000511393, KUMC-HSC-9139-3 |
Study First Received: | October 25, 2006 |
Last Updated: | December 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00392652 |
Health Authority: | Unspecified |
unspecified adult solid tumor, protocol specific |
Healthy |