Study on Metformin for Preventing Oral Cancer in Patients with Oral Leukoplakia or Erythroplakia

Sponsor: University of Arizona

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05237960

Provider View

This clinical trial is exploring whether the drug metformin can help prevent oral cancer in people with white or red patches in their mouth, known as oral leukoplakia or erythroplakia. Metformin is commonly used to control blood sugar levels and may also help stop pre-cancerous changes in the mouth.

Patient Parameters

Program Overview

This study is testing if metformin, a drug usually used to manage blood sugar, can prevent oral cancer in patients with white or red patches in their mouth, called oral leukoplakia or erythroplakia. Metformin works by controlling blood sugar levels and may also help stop changes in the mouth that could lead to cancer. The trial will help researchers understand if metformin can prevent these pre-cancerous changes.

Description

The main goal of this study is to see how metformin affects the cells in the mouth patches. Researchers will look at how the patches respond to metformin treatment and check for changes in cell growth and specific proteins. They will also measure blood sugar and other markers in the blood.

Participants will be randomly assigned to one of two groups. One group will take metformin daily for 24 weeks, while the other group will take a placebo (a pill with no active drug) for the same period. Both groups will have blood samples and mouth biopsies taken at the start and end of the study.

After finishing the treatment, participants will be monitored for up to three weeks to check for any side effects or changes.

Eligibility Criteria

Inclusion Criteria

  • Have white or red patches in the mouth (oral leukoplakia or erythroplakia) with certain cell changes.
  • Lesions must be at least 8x3 mm in size before the first biopsy.
  • Be 21 years or older.
  • Be a current or former smoker with at least 5 packs smoked in their lifetime.
  • Have a performance status score of 70% or higher, meaning able to carry out normal activities.
  • Have certain blood counts and organ function within normal limits.
  • Agree to use effective birth control during the study.
  • HIV-positive patients can participate if their viral load is undetectable.
  • Patients with controlled hepatitis B or cured hepatitis C can participate.
  • Be able to take oral medication and understand the study details.

Exclusion Criteria

  • Have diabetes treated with insulin or other diabetes medications.
  • Have a history of diabetic ketoacidosis.
  • Have taken other experimental drugs in the past 3 months.
  • Have allergies to metformin or similar drugs.
  • Have uncontrolled illnesses or conditions that could interfere with the study.
  • Have oral cancer at the start of the study.
  • Have a history of heavy alcohol use.
  • Have a high blood sugar level (HbA1c > 8%).
  • Be pregnant or breastfeeding.
  • Have liver or kidney disease.
  • Have received certain cancer treatments in the past 18 months.
  • Be taking specific medications like carbonic anhydrase inhibitors or ranolazine.

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