Study on Metformin Hydrochloride to Prevent Oral Cancer in Patients with Oral Premalignant Lesions

Sponsor: National Cancer Institute (NCI)

Sponsor score: 0

ClinicalTrials ID:NCT02581137

This clinical trial is exploring whether the drug metformin hydrochloride can help prevent oral cancer in patients with oral premalignant lesions, such as oral leukoplakia or erythroplakia, which appear as red or white patches in the mouth and may increase cancer risk.

Patient Parameters

Parameter	Options

Program Overview

The aim of this study is to see if metformin hydrochloride can prevent oral cancer in patients with oral premalignant lesions, which are red or white patches in the mouth that don't rub off and may lead to cancer. Metformin hydrochloride might help stop oral cancer from developing in these patients.

Description

The main goal of this study is to see how oral premalignant lesions respond to 12-14 weeks of treatment with metformin hydrochloride. Researchers will also look at how metformin affects certain markers in the tissue and blood that are related to cancer development. These include markers of cell growth and specific genes associated with cancer.

The study will also examine how metformin affects metabolic markers in the blood and saliva, such as C-peptide and glycosylated hemoglobin (HbA1c), as well as levels of metformin in these fluids. Additionally, researchers will explore changes in inflammatory markers and the microbiome in saliva before and after treatment.

Participants will take metformin hydrochloride in an extended-release form once daily for 2 weeks, then twice daily for 10-12 weeks, as long as there are no serious side effects or disease progression. After finishing the treatment, participants will be monitored for 2-4 weeks.

Eligibility Criteria

Inclusion Criteria

Have oral leukoplakia or erythroplakia with mild to severe dysplasia, not caused by mechanical factors like ill-fitted dentures.
Have a measurable lesion at least 8 x 3 mm in size before the initial biopsy.
Have a performance status score of 70% or higher, indicating the ability to carry out daily activities.
Have sufficient blood cell counts and organ function, including:
- White blood cells of at least 3,000/microliter.
- Neutrophil count of at least 1,000/microliter.
- Platelet count of at least 100,000/microliter.
- Total bilirubin and liver enzymes within specified limits.
- Kidney function with eGFR over 40 mL/min.
Have a life expectancy of more than 3 months.
Agree to use effective contraception during the study.
Be able to take oral medication and understand the study, agreeing to sign informed consent.

Exclusion Criteria

Have diabetes and are taking insulin or oral diabetes medications.
Have a history of diabetic ketoacidosis.
Have taken other investigational drugs in the past 3 months.
Have allergies to metformin or similar drugs, or have used metformin in the past year.
Have uncontrolled illnesses, such as active infections, HIV, heart failure, unstable heart conditions, or psychiatric issues that affect study participation.
Have oral carcinoma in situ.
Have a history of chronic alcohol use or abuse, defined as:
- Drinking 3 or more alcoholic beverages daily in the past year.
- Drinking 7 or more alcoholic beverages in a 24-hour period in the past year.
Have a glycated hemoglobin (HbA1c) level over 8%.
Are pregnant or nursing.
Have acute or chronic liver disease, hepatitis, cirrhosis, or portal hypertension.
Have a history of kidney disease.
Have had head and neck cancer unless treated and cancer-free for at least 1 year.
Have received chemotherapy or radiation for any cancer (except non-melanoma skin cancer) in the past 2 years, except ongoing hormonal therapy for breast cancer.

Locations

FACILITY	ZIP	CITY	STATE
UC San Diego Medical Center - Hillcrest	92103	San Diego	California
University of Minnesota/Masonic Cancer Center	55455	Minneapolis	Minnesota

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