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

Part of paid clinical trials in Tucson, Arizona.

Sponsor
University of Arizona
Study ID
NCT05237960
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Erythroplakia
  • Oral Leukoplakia

Eligibility Criteria

Sex
ALL
Age
21 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Biopsy — PROCEDURE
    Undergo biopsy
  • Biospecimen Collection — PROCEDURE
    Correlative studies
  • Extended Release Metformin Hydrochloride — DRUG
    Given PO
  • Placebo Administration — DRUG
    Given PO

Study Details

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.

Key Dates

Start date
Jan 12, 2023
Status verified
Apr 2026
Primary completion
Nov 7, 2025
Completion
Dec 31, 2026

Study Design

Enrollment
34 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Arm I (extended release metformin)
    Patients receive extended release metformin hydrochloride PO QD for 24 weeks in the absence of disease progression or unacceptable toxicity. Patients will also undergo biopsies and blood collections on study.
  • Placebo Comparator: Arm II (placebo)
    Patients receive a placebo PO QD for 24 weeks in the absence of disease progression or unacceptable toxicity. Patients will also undergo biopsies and blood collections on study.

Primary Outcome Measure

Histologic response to metformin [ Time Frame: Up to 24 weeks ]

Locations (8)

FacilityCityStateZIPSite coordinators
University of Arizona Cancer Center-North CampusTucsonArizona85719-
UC San Diego Medical Center - HillcrestSan DiegoCalifornia92103-
Moffitt Cancer CenterTampaFlorida33612-
Emory University Hospital/Winship Cancer InstituteAtlantaGeorgia30322-
Louisiana State UniversityLafayetteLouisiana70503-
University of Michigan Comprehensive Cancer CenterAnn ArborMichigan48109-
University of Minnesota/Masonic Cancer CenterMinneapolisMinnesota55455-
NYU College of DentistryNew YorkNew York10010-

Find similar trials in Tucson, AZ

By research site
University of Arizona Cancer Center-North Campus· Tucson, AZUC San Diego Medical Center - Hillcrest· San Diego, CAMoffitt Cancer Center· Tampa, FLEmory University Hospital/Winship Cancer Institute· Atlanta, GALouisiana State University· Lafayette, LAUniversity of Michigan Comprehensive Cancer Center· Ann Arbor, MI

Related Studies