Metformin for the Prevention of Oral Cancer in Patients With Oral

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05237960
Study type	Interventional
Source	University of Arizona
Contact
Status	Recruiting
Phase	Phase 2
Start date	January 12, 2023
Completion date	August 31, 2028

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See also
Status	Clinical Trial	Phase
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Terminated	`NCT00176566` - A Phase II Trial to Assess the Effects of Green Tea in Oral Leukoplakia	Phase 2
Completed	`NCT03682562` - Diagnostic Accuracy of Salivary DNA Integrity Index in Oral Malignant and Premalignant Lesions
Completed	`NCT04153266` - Oral Epithelial Dysplasia Informational Needs Questionnaire
Completed	`NCT04712929` - Candida Associated Cytokines in Oral Leukoplakia
Completed	`NCT03031899` - Comparison or Rose Bengal and Toluidine Blue Staining for Lesion Detection Efficacy
Terminated	`NCT00571558` - Photodynamic Therapy Using Aminolevulinic Acid in Treating Patients With Oral Leukoplakia	Phase 1
Recruiting	`NCT06321003` - SYsteMatical Trained learnIng aLgorithms for Oral carcInogenesiS Interpretation by Optical Coherence Tomography
Not yet recruiting	`NCT04732741` - Diagnostic Accuracy of Salivary Gamma-synuclein in Oral Malignant and Premalignant Lesions
Completed	`NCT00369174` - Rosiglitazone Maleate in Treating Patients With Oral Leukoplakia	Phase 2
Completed	`NCT00099021` - Pioglitazone Hydrochloride in Preventing Head and Neck Cancer in Patients With Oral Leukoplakia	Phase 2
Not yet recruiting	`NCT05727761` - Pioglitazone-Metformin Combination Treatment for High Risk Oral Preneoplasia	Phase 2
Active, not recruiting	`NCT02581137` - Metformin Hydrochloride in Preventing Oral Cancer in Patients With an Oral Premalignant Lesion	Phase 2
Recruiting	`NCT05942794` - Identification of Oral Lesions Through an Autofluorescence System	N/A
Completed	`NCT00330382` - Bowman-Birk Inhibitor Concentrate in Preventing Cancer in Patients With Oral Leukoplakia	Phase 2
Not yet recruiting	`NCT06256809` - Analyzing Handprint Patterns to Predict Oral Cancer Risks: A Comparative Study
Completed	`NCT00951379` - Pioglitazone for Oral Premalignant Lesions	Phase 2
Recruiting	`NCT04251845` - Evaluation of Effect of Topical Melatonin in Treatment of Oral Leukoplakia	N/A
Terminated	`NCT04079491` - Intra and Extra Oral Inspection of Oral Mucosa
Recruiting	`NCT00767442` - Least Invasive Nonlinear Light Microscopy	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms