Metformin for the Prevention of Oral Cancer in Patients With Oral Leukoplakia or Erythroplakia (NCT05237960)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (18 items) and avoid the listed exclusions (14 items).
Location: University of Arizona Cancer Center-North Campus — Tucson, Arizona
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- Patients with diabetes who are being treated with insulin or an anti-diabetic medication
- History of diabetic ketoacidosis
- Participants may not be receiving any other investigational agents within past 3 months at screening
- History of allergic reactions attributed to compounds of similar chemical composition to metformin or prior use of metformin within the last year
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, human immunodeficiency virus (HIV) positive, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Oral carcinoma in situ from the baseline biopsy
- History of chronic alcohol use or abuse defined as any one of the following: a) average consumption of 3 or more alcohol containing beverages daily in the past 12 months; b) consumption of 7 or more alcoholic beverages within a 24 hour (hr) period in the past 12 months
- Hemoglobin A1c (HbA1c) \> 8%
- Pregnancy or nursing women. Pregnant women are excluded from this study because the effects of metformin on the developing human fetus are unknown even though it is not teratogenic in rats and rabbits at 2-6 times the maximum recommended human daily dose. Because there is an unknown but potential risk for AEs in nursing infants secondary to treatment of the mother with metformin, breastfeeding should be discontinued
- Acute or chronic liver disease, evidence of hepatitis (infectious or autoimmune), cirrhosis or portal hypertension
- History of renal disease
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (10 Sites)
- University of Arizona Cancer Center-North Campus — Tucson, Arizona
- UC San Diego Medical Center - Hillcrest — San Diego, California
- Moffitt Cancer Center — Tampa, Florida
- Emory University Hospital/Winship Cancer Institute — Atlanta, Georgia
- Louisiana State University — Lafayette, Louisiana
- University of Michigan Comprehensive Cancer Center — Ann Arbor, Michigan
- University of Minnesota/Masonic Cancer Center — Minneapolis, Minnesota
- NYU College of Dentistry — New York, New York
- British Columbia Cancer Agency — Vancouver, British Columbia
- Dalhousie University — Halifax, Nova Scotia
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.