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

Active:	Yes
Cancer Type:	Unknown Primary	NCT ID:	NCT05237960
Trial Phases:	Phase II	Protocol IDs:	Pending12 (primary) UAZ21-07-01 NCI-2022-00596
Eligibility:	21 Years and older, Male and Female	Study Type:	Prevention
Study Sponsor:	University of Arizona Cancer Center - Prevention Research Clinic
NCI Full Details:	http://clinicaltrials.gov/show/NCT05237960

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.

Objectives

PRIMARY OBJECTIVE:
I. To determine the histological response to metformin hydrochloride (metformin) intervention in the target lesion.

SECONDARY OBJECTIVES:
I. Clinical response to metformin intervention in the target lesion.
II. Effect of metformin on cell proliferation (Ki67) and its molecular targets (pS6 and nuclear YAP) in the target lesion.
III. Metformin effect on serum metabolic markers (C-peptide, glucose and HbA1c).
IV. Trough plasma metformin concentrations.

EXPLORATORY OBJECTIVES:
I. Expression of dysregulated molecular mechanisms in the target lesion, including, in order of priority, p53, PTEN, p16, EGFR, and pEGFR.
II. Immune cell infiltration and markers of inflammation in the target lesion.
III. Analysis of genomic alterations in the target lesion and blood deoxyribonucleic acid (DNA).
IV. Microbiome in oral rinses.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients receive extended release metformin hydrochloride orally (PO) once daily (QD) for 24 weeks in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of blood and biopsy at baseline and week 24.

ARM II: Patients receive a placebo PO QD for 24 weeks in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of blood and biopsy at baseline and week 24.

After completion of study treatment, patients are followed for up to 3 weeks.

Treatment Sites in Georgia

Winship Cancer Institute of Emory University
1365 Clifton Road NE
Building C
Atlanta, GA 30322
404-778-5180
winshipcancer.emory.edu

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.