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NCT05237960 · ClinicalTrials.gov registry record · Phase 2
Metformin for the Prevention of Oral Cancer in Patients With Oral Leukoplakia or Erythroplakia
A Phase 2 study of Oral Leukoplakia and Erythroplakia, sponsored by University of Arizona.
- Active
- Registry status
- Phase 2
- Development phase
- 34
- Enrollment target
- 10
- Study locations
NCT05237960: Active Phase 2 study of Oral Leukoplakia and Erythroplakia, sponsored by University of Arizona.
NCT05237960 is a Phase 2 study of Oral Leukoplakia and Erythroplakia that is active but no longer recruiting, run by University of Arizona. The registered enrollment target is 34 participants, below the 42-participant average among 4 other Oral Leukoplakia trials with a reported enrollment target (19% lower). The trial reports 10 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05237960, a Phase 2 study of Oral Leukoplakia and Erythroplakia, is active but no longer recruiting, sponsored by University of Arizona.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 34 participants
- Enrollment target
- 10
- Study locations
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.
Primary Outcome
Histologic response will be evaluated by the following criteria: complete response (CR): Complete reversal of dysplasia or hyperplasia to normal epithelium in the target lesion. Partial response (PR): Improvement of the degree of dysplasia or hyperplasia in the target lesion. No change (NC): No change in the degree of dysplasia or hyperplasia in the target lesion, anything that is not CR, PR or PD. Progressive disease (PD): Increase in the severity of grade of histology in the target lesion. His
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 34 participants |
| Start Date | 2023-01-12 |
| Est. Completion | 2026-12 |
| Phase | Phase 2 |
What the registry record for NCT05237960 still lists
NCT05237960 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 34 participants, a relatively small participant target, below the 42-participant average among 4 other Oral Leukoplakia trials with a reported enrollment target (19% lower).
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.
NCT05237960 lists 10 locations in 10 states (Arizona, California, Florida).
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.
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).
Who is sponsoring clinical trial NCT05237960?
This trial is sponsored by University of Arizona, which has 349 total clinical trials registered on ClinicalTrials.gov.
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.
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