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Bowman-Birk Inhibitor Concentrate in Preventing Cancer in Patients With Oral Leukoplakia

NCT00330382 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 325

Last updated 2014-12-19

Study results available
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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

Conditions

  • Lip and Oral Cavity Cancer
  • Oral Leukoplakia
  • Oropharyngeal Cancer
  • Tongue Cancer

Interventions

DRUG

Bowman-Birk inhibitor concentrate

Given orally

OTHER

placebo

Given orally

OTHER

laboratory biomarker analysis

Correlative studies

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Frank Meyskens · University of California Medical Center At Irvine-Orange Campus

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1999-01-31
Primary Completion
2010-07-31
Completion
2013-05-31

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00330382 on ClinicalTrials.gov