CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 325 enrolled
Drug / intervention
Bowman-Birk inhibitor concentrate +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00330382
NCT00330382Phase 2Completed
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Bowman Birk Inhibitor Concentrate and Oral Leukoplakia: A Randomized Phase IIb Trial

National Cancer Institute (NCI)·interventional·Posted May 26, 2006·Updated Dec 19, 2014

In Brief

A Phase 2 clinical trial evaluating Bowman-Birk inhibitor concentrate, placebo, and 1 other intervention for Lip and Oral Cavity Cancer and 3 related conditions. Completed, enrolled 325 participants across 1 site.

Detailed Summary

This randomized phase II trial is studying how well Bowman-Birk inhibitor concentrate works in preventing cancer in patients with oral leukoplakia. Chemoprevention is the use of certain substances to keep cancer from forming, growing, or coming back. The use of Bowman-Birk inhibitor concentrate, a substance made from soy, may keep cancer from forming in patients with oral leukoplakia

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLip and Oral Cavity Cancer, Oral Leukoplakia, Oropharyngeal Cancer, Tongue Cancer
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
19992000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 26, 2006
Enrollment StartJan 1, 1999
Primary CompletionJul 1, 2010
Study CompletionMay 1, 2013
TodayJul 2, 2026
Enrollment to primary: 11.5 yearsPosted 20.1 years ago

Interventions

Bowman-Birk inhibitor concentratedrug

Given orally

placeboother

Given orally

laboratory biomarker analysisother

Correlative studies