drugset / Trial / NCT03685409

Cancer Chemoprevention by Metformin Hydrochloride in Oral Potentially Malignant Lesions

NCT03685409 ↗

Phase 3 Unknown 62 enrolled Cairo University
RandomizedParallel-groupSingle-blindPrevention

Summary

Oral squamous cell carcinomas (OSCCs) are among the most common types of head and neck cancers and are a major cause of significant morbidity. It was reported that 16- 62% of OSCCs develop from premalignant lesions, which often presents clinically as white or red mucosal patches known as leukoplakia and erythroplakia. The role of miRNA in cancer has been established by many studies that have shown that miRNA signatures (i.e., mRNA expression profiles) can be useful for classifying human cancers. These studies have identified "cancer related miRNAs through investigating expression profiles in matched normal and tumor tissues, as well as in body fluids. Metformin, one of most widely prescribed oral hypoglycemic agents, has recently received increased attention because of its potential anti-tumorigenic effects that are thought to be independent of its hypoglycemic effects. Evans et al. first found an association between metformin use and decreased cancer incidence. The study will reveal whether Systemic Metformin hydrochloride treatment given to patients with oral potentially malignant lesions improve the prognosis and prevent or at least reduce the incidence of malignant transformation?

Timeline

Start
2018-10-01
Primary completion
2019-09-30
Completion
2020-09-30

Drugs

EvaluationDrugModalityDoseRoute
Comparator Metformin Small molecule 500 mg Oral

Indications