TerminatedPhase 1

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

Stopped: Slow accrual

United States4 participantsStarted 2022-05-04

Plain-language 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.

Who can participate

Age range

18 Years – 85 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age 18-85 * Clinical appearance of lesion * Homogenous leukoplakia * Non- homogenous leukoplakia * Erythroplakia * Proliferative verrucous leukoplakia * Histologic appearance * No dysplasia * Mild dysplasia * Moderate dysplasia * Severe dysplasia * Diabetics: if on metformin, will get them to 2000 mg per day, if not, will add metformin in consultation with endocrinologist * All subjects must be able to comprehend and sign a written informed consent document * Willing and able to be available for the duration of the study * In general good health with no contraindication to biopsy or metformin therapy * Laboratory results Exclusion Criteria: * Carcinoma in-situ, verrucous carcinoma, invasive squamous cell carcinoma (SCCa) * Exclude systemic causes of the lesion: pemphigus, pemphigoid, systemic lupus erythematosus (SLE), lichenoid drug reaction, human immunodeficiency virus (HIV), syphilis * Exclude local inciting factors: rule out (r/o) but allowing 2 weeks to pass and see if there is resolution, if not and doesn't resolve with local measures, medical treatment, enroll * Frictional: sharp tooth * Trauma * Immunosuppression by natural illness or medically induced * Hypersensitivity or allergic reaction to metformin or some other contraindication

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Transformation-free-survival, in lesion types erythroplakia and verrucous hyperplasia

Timeframe: Up to 3 years

Trial details

NCT IDNCT05536037

SponsorThomas Jefferson University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-03-16

View on ClinicalTrials.gov More Erythroplakia trials