What side effects are associated with this type of intervention?

Common treatments for erythroplakia include surgical excision, laser therapy, and cryotherapy. For treatments similar to metformin, which is being studied for its potential in preventing oral cancer, the side effects include gastrointestinal issues such as nausea, vomiting, diarrhea, and abdominal discomfort. Metformin can also cause lactic acidosis, particularly in patients with renal impairment or other contraindications. Weight loss and decreased vitamin B12 levels are other potential side effects. It is important to monitor patients for these adverse effects and adjust treatment as necessary.

What prior FDA approvals exist?

There are no specific FDA-approved treatments for erythroplakia mentioned in the provided context. However, metformin, which decreases glucose absorption and production and increases insulin sensitivity, is currently being studied in a trial for its potential to prevent oral cancer in patients with oral leukoplakia or erythroplakia. This suggests a possible future role for metformin in managing these conditions.

What other types of research exist?

Currently, there are no specific novel alternatives to Metformin mentioned for the treatment of Erythroplakia in the provided context. However, GLP-1 receptor agonists, such as liraglutide and semaglutide, are promising alternatives for managing glucose levels and may offer additional benefits. Patients should discuss these options with their healthcare provider.

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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

Must not have

History of allergic reactions attributed to compounds of similar chemical composition to metformin or prior use of metformin within the last year

Current use of carbonic anhydrase inhibitors (e.g. topiramate, zonisamide, acetazolamide, or dichlorphenamide) or ranolazine

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 24 weeks

Summary

This trial tests if metformin can prevent oral cancer in patients with pre-cancerous mouth patches. Metformin is a diabetes drug that controls blood sugar and may stop these patches from becoming cancerous. Metformin, widely used as a diabetes medication, has recently been reported to reduce cancer risk and improve outcomes in certain cancers.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had allergic reactions to metformin or similar drugs, or I've used metformin in the last year.

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I am currently taking medication like topiramate or ranolazine.

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I am not pregnant or nursing.

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I have a history of kidney disease.

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I have liver disease, hepatitis, cirrhosis, or portal hypertension.

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I have a diagnosis of early-stage mouth cancer.

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I do not have any uncontrolled illnesses that could affect my participation.

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I have had diabetic ketoacidosis in the past.

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I am being treated for diabetes with insulin or other medications.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Histologic response to metformin

Secondary study objectives

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 3

~2020

0 / 15Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Erythroplakia, such as Metformin, work by controlling glucose levels in the body. Metformin decreases the amount of glucose absorbed from food and produced by the liver, while also increasing the body's sensitivity to insulin. This is important for Erythroplakia patients because high glucose levels can lead to cellular changes that may progress to cancer. By managing glucose levels, Metformin may help prevent these pre-cancerous changes. Other chemoprevention strategies aim to inhibit cancer development through various mechanisms, including reducing inflammation and cellular proliferation.

Bioluminescence assay of enzymes obtained from buccal epithelium by superficial scraping.European School of Oncology Advisory report to the European Commission for the Europe Against Cancer Programme: oral carcinogenesis in Europe.Exfoliative cytology of buccal squames: A quantitative cytomorphometric analysis of patients with diabetes.