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Cancer Chemoprevention by Metformin Hydrochloride in Oral Potentially Malignant Lesions

NCT03685409 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 62

Last updated 2018-09-26

No results posted yet for this study

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?

Conditions

  • Oral Cancer

Interventions

DRUG

Metformin Hydrochloride 500 MG

Metformin hydrochloride tablets 500 mg given orally once daily.

DRUG

Placebo Oral Tablet

Starch Placebo oral tablets will be given once daily to the control group

Sponsors & Collaborators

  • Cairo University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • Egypt

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03685409 on ClinicalTrials.gov