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NCT00450229 · ClinicalTrials.gov registry record · Phase 1
Diindolylmethane in Treating Patients Undergoing Surgery for Stage I or Stage II Prostate Cancer
A Phase 1 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 1
- Development phase
- 45
- Enrollment target
NCT00450229: Completed Phase 1 study, sponsored by National Cancer Institute (NCI).
NCT00450229 is a Phase 1 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 45 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (25% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00450229, a Phase 1 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 45 participants
- Enrollment target
Study Summary
Giving diindolylmethane, a substance found in cruciferous vegetables, may help doctors learn more about how diindolylmethane is used by the body. This randomized phase I trial is studying the side effects and best dose of diindolylmethane compared with a placebo in treating patients undergoing radical prostatectomy for stage I or stage II prostate cancer.
Primary Outcome
The distribution of levels of DIM will be summarized by treatment arm with descriptive statistics. For the primary comparison between the placebo group and the DIM groups combined, tissue levels of DIM will be compared using Student t-test. In the case of violation of normality assumptions, an appropriate transformation of the data such as logarithm will be considered or a nonparametric test such as Wilcoxon rank-sum test will be used for comparison. A dose-response relation will be explored bas
Interventions
- DRUG placebo
- OTHER laboratory biomarker analysis
- PROCEDURE therapeutic conventional surgery
- OTHER pharmacological study
- DRUG diindolylmethane
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 45 participants |
| Start Date | 2007-02 |
| Est. Completion | 2010-02 |
| Phase | Phase 1 |
What the finished NCT00450229 record still lists
NCT00450229 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 45 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (25% lower).
The record links to 0 conditions, and to 5 interventions - of which placebo is the first listed.
NCT00450229 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00450229 about?
NCT00450229 is a clinical study titled "Diindolylmethane in Treating Patients Undergoing Surgery for Stage I or Stage II Prostate Cancer". Giving diindolylmethane, a substance found in cruciferous vegetables, may help doctors learn more about how diindolylmethane is used by the body. This randomized phase I trial is studying the side effects and best dose of diindolylmethane compared with a placebo in treating patients undergoing radic...
What is the current status of trial NCT00450229?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 45 participants. The study started on 2007-02. Estimated completion is 2010-02.
What interventions are being tested in trial NCT00450229?
The interventions under investigation include: placebo (DRUG), laboratory biomarker analysis (OTHER), therapeutic conventional surgery (PROCEDURE), pharmacological study (OTHER), diindolylmethane (DRUG).
Who is sponsoring clinical trial NCT00450229?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00450229's enrollment target sits among peer trials
45 1066th of 2000 higher than 915 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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