Clinical Trial

Metformin for the Prevention of Oral Cancer in Patients With Oral Leukoplakia or Erythroplakia

Active, Not Recruiting Phase 2
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Summary
This phase IIb trial tests whether metformin works in preventing oral cancer in patients with oral leukoplakia (white patches) or erythroplakia (red patches). Metformin is in a class of drugs called biguanides. Metformin helps to control the amount of glucose (sugar) in the blood. It decreases the amount of glucose patients absorb from food and the amount of glucose made by the liver. Metformin also increases the body's response to insulin, a natural substance that controls the amount of glucose in the blood. This trial may help researchers determine if metformin can stop changes in the mouth that are related to pre-cancer growths in the mouth.
Protocol Amendment History 20 amendments
This ClinicalTrials.gov record has been amended 20 times since 2022-02-10; most recent amendment 2026-04-15.
Status change: Recruiting → Active, Not Recruiting 2025-05-27
Status change: Not Yet Recruiting → Recruiting 2023-02-18
Trial Details
NCT Number NCT05237960
Lead Sponsor University of Arizona
Collaborators: National Cancer Institute (NCI)
Conditions Erythroplakia, Oral Leukoplakia
Enrollment 34 participants
Start Date 2023-01-12
Primary Completion 2025-11-07 (estimated)
Study Completion 2026-12 (estimated)
Updated on ClinicalTrials.gov 2026-04-20