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Metformin Hydrochloride in Preventing Oral Cancer in Patients With an Oral Premalignant Lesion

NCT02581137 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2026-04-13

Study results available
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Summary

This phase IIa trial studies how well metformin hydrochloride works in preventing oral cancer in patients with an oral premalignant lesion (oral leukoplakia or erythroplakia). Oral premalignant lesions look like red or whitish plaques or lesions in the mouth that do not rub off and can be associated with a higher risk of cancer. Metformin hydrochloride may help prevent oral cancer from forming in patients with an oral premalignant lesion.

Conditions

  • Erythroplakia
  • Hyperplasia
  • Oral Cavity Carcinoma
  • Oral Leukoplakia

Interventions

OTHER

Laboratory Biomarker Analysis

Correlative studies

DRUG

Metformin Hydrochloride

Given PO

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Scott M Lippman · The University of Arizona Medical Center-University Campus

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-06-10
Primary Completion
2017-10-12
Completion
2026-12-19

Countries

  • United States
  • Canada

Study Locations

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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 NCT02581137 on ClinicalTrials.gov