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Metformin for the Prevention of Oral Cancer in Patients With Oral Premalignant Lesions

NCT05536037 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2025-05-15

No results posted yet for this study

Summary

This phase I trial tests whether metformin works in reducing the annual transformation (development of invasive cancer) of oral precancerous lesions into cancerous lesions. Metformin is a drug approved for the treatment of diabetes, but studies have shown that it may have some anticancer properties. Giving metformin may help prevent or slow the development of oral cancer from precancerous lesions.

Conditions

  • Erythroplakia
  • Leukoplakia
  • Oral Cavity Carcinoma
  • Proliferative Verrucous Leukoplakia

Interventions

DRUG

Metformin

Given PO

PROCEDURE

Biopsy

Undergo biopsy

Sponsors & Collaborators

  • Thomas Jefferson University

    lead OTHER

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-04
Primary Completion
2024-03-16
Completion
2024-03-16
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT05536037 on ClinicalTrials.gov