RecruitingPhase 2NCT05727761

Pioglitazone-Metformin Combination Treatment for High Risk Oral Preneoplasia

Sponsor

University of Minnesota

Enrollment

36 participants

Start Date

Jan 1, 2025

Study Type

INTERVENTIONAL

Conditions

Oral Leukoplakia

Summary

This is a Phase IIa oral cavity leukoplakia study of pioglitazone 15mg and metformin 500mg BID for 12 weeks. The primary objective is to determine the clinical and histologic changes of leukoplakia from baseline following a 12 week course of twice daily pioglitazone-metformin. Outcomes are defined as are a reduction of the leukoplakia grade in \> 50% of treated participants and a partial or complete clinical response defined as 50% or greater reduction in the sum of measured targeted lesions. In addition, participants who show clinical and histologic improvement should correlate with a significant reduction of Ki-67 proliferative indices in lesions of these participants as compared to baseline.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a combination of two diabetes drugs — pioglitazone and metformin — can shrink or stop precancerous lesions in the mouth (called oral leukoplakia or dysplasia), which can develop into oral cancer if untreated. **You may be eligible if...** - You are 18 or older - You have a biopsy-confirmed precancerous lesion in your mouth or throat (oral leukoplakia, erythroplakia, or dysplasia) - The lesion is measurable and accessible for follow-up biopsy **You may NOT be eligible if...** - You have already progressed to oral cancer - You have diabetes or other conditions that make these drugs unsafe - You are taking medications that interact with pioglitazone or metformin Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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