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Search / Trial NCT03684707

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

Launched by AIN SHAMS UNIVERSITY · Sep 24, 2018

Trial Information

Current as of May 22, 2025

Unknown status

Keywords

ClinConnect 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 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 expre...

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 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.
  • 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 (atrophic lichen planus- leukoplakia-erythroplakia - oral submucous fibrosis)
  • Exclusion Criteria:
  • - 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 or Retinoids 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...

About Ain Shams University

Ain Shams University, established in Cairo, Egypt, is a prestigious higher education institution renowned for its commitment to academic excellence and research innovation. As a clinical trial sponsor, the university leverages its extensive resources and expertise in various medical and scientific disciplines to advance healthcare through rigorous research initiatives. With a focus on ethical practices and adherence to regulatory standards, Ain Shams University aims to contribute to the development of new therapies and improve patient outcomes, fostering collaboration among researchers, healthcare professionals, and industry partners in the pursuit of medical advancements.

Locations

Cairo, New Cairo, Egypt

Patients applied

0 patients applied

Trial Officials

Fathia Z. Zahran, PHD

Study Chair

Cairo University

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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