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ACTIVE NOT RECRUITING Phase 2

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

NCT05237960 · View on ClinicalTrials.gov ↗

Study Summary

This phase IIb trial tests whether metformin works in preventing oral cancer in patients with oral leukoplakia (white patches) or erythroplakia (red patches). Metformin is in a class of drugs called biguanides. Metformin helps to control the amount of glucose (sugar) in the blood. It decreases the amount of glucose patients absorb from food and the amount of glucose made by the liver. Metformin also increases the body's response to insulin, a natural substance that controls the amount of glucose in the blood. This trial may help researchers determine if metformin can stop changes in the mouth that are related to pre-cancer growths in the mouth.

Interventions

  • PROCEDURE Biospecimen Collection
  • PROCEDURE Biopsy
  • DRUG Placebo Administration
  • DRUG Extended Release Metformin Hydrochloride

Study Locations (10)

Arizona

  • University of Arizona Cancer Center-North Campus — Tucson

California

  • UC San Diego Medical Center - Hillcrest — San Diego

Florida

  • Moffitt Cancer Center — Tampa

Georgia

  • Emory University Hospital/Winship Cancer Institute — Atlanta

Louisiana

  • Louisiana State University — Lafayette

Michigan

  • University of Michigan Comprehensive Cancer Center — Ann Arbor

Minnesota

  • University of Minnesota/Masonic Cancer Center — Minneapolis

New York

  • NYU College of Dentistry — New York

Trial Details

FieldValue
Enrollment Target 34 participants
Start Date 2023-01-12
Est. Completion 2026-12
Phase Phase 2

Sponsor

University of Arizona

379 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05237960

The ClinicalTrials.gov registry entry for NCT05237960 describes a study currently listed as active not recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 34 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Arizona, which has 379 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 2 conditions, with Oral Leukoplakia appearing as the primary indexed condition, and to 4 interventions — of which Biospecimen Collection is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05237960 reports 10 study locations spanning 10 distinct geographic areas — top geographies include Arizona, California, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT05237960 about?

NCT05237960 is a clinical study titled "Metformin for the Prevention of Oral Cancer in Patients With Oral Leukoplakia or Erythroplakia". This phase IIb trial tests whether metformin works in preventing oral cancer in patients with oral leukoplakia (white patches) or erythroplakia (red patches). Metformin is in a class of drugs called biguanides. Metformin helps to control the amount of glucose (sugar) in the blood. It decreases the a...

What is the current status of trial NCT05237960?

This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 34 participants. The study started on 2023-01-12. Estimated completion is 2026-12.

What conditions does trial NCT05237960 study?

This clinical trial studies the following conditions: Oral Leukoplakia, Erythroplakia. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05237960?

The interventions under investigation include: Biospecimen Collection (PROCEDURE), Biopsy (PROCEDURE), Placebo Administration (DRUG), Extended Release Metformin Hydrochloride (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05237960?

This trial is sponsored by University of Arizona, which has 379 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT05237960 being conducted?

This trial has 10 study locations across Arizona, California, Florida, Georgia, Louisiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial