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Biguanide

Metformin for Oral Leukoplakia/Erythroplakia Prevention

Phase 2

Recruiting

Led By Scott M Lippman

Research Sponsored by University of Arizona

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participants with oral leukoplakia or erythroplakia with mild, moderate, or severe histologic dysplasia or hyperplasia at the high risk sites (e.g., floor of mouth, tongue). Lesions arising from the radiation field are excluded as study lesions.

Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 24 weeks

Awards & highlights

Study Summary

This trial is testing whether metformin can help prevent oral cancer in patients with precancerous mouth conditions.

Who is the study for?

Adults over 21 with oral leukoplakia or erythroplakia, not caused by radiation, and certain health criteria met (e.g., kidney function). Smokers are eligible. Excludes those allergic to metformin, heavy alcohol users, recent cancer treatments other than skin/certain organ-confined cancers, uncontrolled diseases, pregnant/nursing women.Check my eligibility

What is being tested?

This trial is testing if extended-release metformin can prevent oral cancer in patients with white or red patches in their mouth. Participants will either receive metformin or a placebo while undergoing biopsies and biospecimen collection to monitor changes.See study design

What are the potential side effects?

Metformin may cause digestive issues like nausea and diarrhea, potential vitamin B12 deficiency with long-term use, and rarely lactic acidosis—a serious metabolic complication.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have oral leukoplakia or erythroplakia with abnormal cell growth in high-risk areas, but not from radiation.

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I had hepatitis C but am cured, or I'm being treated with no detectable virus.

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I have smoked at least 5 packs of cigarettes in my lifetime.

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My hepatitis B virus load is undetectable with treatment.

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I am able to care for myself but may not be able to do active work.

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I am on long-term antiviral treatment for herpes simplex virus.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 24 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 24 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Histologic response to metformin

Secondary outcome measures

Cell proliferation

Clinical response to metformin

Plasma metformin concentrations

+1 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Arm I (extended release metformin)Experimental Treatment3 Interventions

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.

Group II: Arm II (placebo)Placebo Group3 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Biopsy

2014

Completed Phase 4

~1090

Biospecimen Collection

2004

Completed Phase 2

~1700

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of ArizonaLead Sponsor

514 Previous Clinical Trials

148,508 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,664 Previous Clinical Trials

40,926,047 Total Patients Enrolled

3 Trials studying Erythroplakia

368 Patients Enrolled for Erythroplakia

Scott M LippmanPrincipal InvestigatorUniversity of California, San Diego Moores Cancer Center

1 Previous Clinical Trials

26 Total Patients Enrolled

1 Trials studying Erythroplakia

26 Patients Enrolled for Erythroplakia

Media Library

Extended Release Metformin Hydrochloride (Biguanide) Clinical Trial Eligibility Overview. Trial Name: NCT05237960 — Phase 2

Erythroplakia Research Study Groups: Arm I (extended release metformin), Arm II (placebo)

Erythroplakia Clinical Trial 2023: Extended Release Metformin Hydrochloride Highlights & Side Effects. Trial Name: NCT05237960 — Phase 2

Extended Release Metformin Hydrochloride (Biguanide) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05237960 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any dangers associated with taking Extended Release Metformin Hydrochloride?

"Given that this is a Phase 2 trial, meaning there is only limited safety data available, our team at Power has given Extended Release Metformin Hydrochloride a score of 2."

Answered by AI

In how many different medical clinics is this clinical trial being performed today?

"Enrollment for this clinical trial is currently happening at 11 different sites. These locations include Atlanta, Lafayette, Tampa and 8 other places. If you are considering participating in this research project, please choose the site that is most convenient for you to reduce travel-related stressors."

Answered by AI

Are there any spots still available for volunteers in this experiment?

"The clinicaltrials.gov website reports that this study is inactive and not presently seeking patients for participation. The trial was first posted on March 25th, 2023 and edited for the last time on October 13th, 2022. Although this research is not recruiting right now, there are 78 other trials that are currently looking for volunteers."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2022. "Metformin for the Prevention of Oral Cancer in Patients With Oral Leukoplakia or Erythroplakia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05237960.