NCT03684707

Cancer Chemoprevention by Metformin Hydrochloride Compared to Placebo in Oral Potentially Malignant Lesions

Cancer Chemoprevention by Metformin Hydrochloride Compared to Placebo in Oral Potentially Malignant Lesions: A Randomised Clinical Trial

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Ain Shams University · Academic / Other
• Sex: All
• Age: 20 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

Evaluation of the metformin drug effect as a drug that found to improve the quality of tissues, decrease signs \& symptoms of cancer, and decrease histo-pathological criteria of dysplasia. This will be done by the aid of measuring salivary Micro RNA 31 \& 210 in saliva in addition to measure cyclin A2 as an immuno-histochemical analysis.

Detailed description

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 reiterated and 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. In addition, a vast number of studies have shown that miRNAs can play a role in regulating the expression of oncogenes and tumor suppressor genes, whereas others have shown that miRNA gene deletion or mutation can lead cancer initiation, progression and metastasis . Several potential mechanisms have been suggested for the ability of metformin to suppress cancer growth in vitro and vivo: (1) Activation of LKB1/AMPK pathway, (2) Induction of cell cycle arrest and/or apoptosis, (3) Inhibition of protein synthesis, (4) Reduction in circulating insulin levels, (5) Inhibition of the unfolded protein response (UPR), (6) Activation of the immune system. This study is performed to evaluate metformin effect on the patients premalignant lesion versus maintenace follow ups.

Conditions

• Oral Cancer

Interventions

Type	Name	Description
DRUG	Metformin Hcl 500Mg 24Hr Sa Tab	Glucophage 500 mg once daily
OTHER	starch tablet	starch tablets

Timeline

• Start date: 2018-09-15
• Primary completion: 2019-06-15
• Completion: 2019-09-15
• First posted: 2018-09-26
• Last updated: 2018-09-26

Locations

1 site across 1 country: Egypt

Regulatory

• FDA-regulated drug study