Cancer Chemoprevention by Metformin Hydrochloride in Oral Potentially Malignant Lesions

NCT03685409 | Unknown Phase 3

• 1 other identifier: 023836530
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Clinical Outcomes

  Effect of Systemic Metformin hydrochloride on the millimeters change in the largest diameter of the oral potentially malignant lesion

  3 months

Secondary Outcomes (3)

• Immunohistochemical analysis

  3 months

• microRNA analysis

  3 months

• Salivary microRNA

  3 months

Study Arms (2)

Metformin-Group

ACTIVE COMPARATOR

Metformin hydrochloride tablets 500 mg taken orally once daily for 3 months

Drug: Metformin Hydrochloride 500 MG

Placebo-Group

PLACEBO COMPARATOR

Starch placebo tablets taken orally once daily for 3 months

Drug: Placebo Oral Tablet

Interventions

Metformin Hydrochloride 500 MG DRUG

Metformin hydrochloride tablets 500 mg given orally once daily.

Also known as: Glucophage, Cidophage

Metformin-Group

Placebo Oral Tablet DRUG

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

Placebo-Group

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Both genders with age range from 20 to 70 years.
• Patients able to return for the follow up visits and can perform oral hygiene measures.
• Clinically diagnosed and histologically confirmed as having oral potentially malignant lesions (Atrophic oral lichen planus, leukoplakia, erythroplakia and oral submucous fibrosis).
• Patients agreed to sign a written consent after understanding the nature of the study
• Patients have diagnosed oral premalignant lesion/lesions and not yet turned into malignancy

You may not qualify if:

• Diabetic patients (Diabetes Mellitus Type I \& II)
• Patients have cardiovascular, lung, Renal, Liver diseases
• Patients on H2 blocker \& proton pump inhibitors therapy as Ranitidine (affects metformin absorption and clearance)
• Those with allergy or sensitivity to Metformin therapy or having any contraindication for their use.
• Systemic and/or local systemic drug therapy within the last 3 months prior to the start of the study
• Patients on steroidal or Non-steroidal anti-inflammatory drugs (NSAIDs) for at least the last 6 months
• Patients on Antibiotics treatment for at least the last 2 months
• Patients on Retinoid, green tea supplements or another natural products therapy
• Patients with already diagnosed malignant lesion/lesions
• Pregnant or Lactating females
• Vulnerable groups as prisoners, mentally disabled, etc…

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Dentistry- Cairo University

Cairo, Egypt

RECRUITING

MeSH Terms

Conditions

Mouth Neoplasms

Interventions

Metformin

Condition Hierarchy (Ancestors)

Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer

Study Record Dates

• First Submitted: September 24, 2018
• First Posted: September 26, 2018
• Study Start: October 1, 2018
• Primary Completion: September 30, 2019
• Study Completion: September 30, 2020
• Last Updated: September 26, 2018

Record last verified: 2018-09

Locations

EG (1)