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Cancer Chemoprevention by Metformin Hydrochloride in Oral Potentially Malignant Lesions

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03685409
Recruitment Status : Recruiting
First Posted : September 26, 2018
Last Update Posted : September 26, 2018
Information provided by (Responsible Party):
Ahmed Adel Mohamed Abdelazim, Cairo University

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?

Condition or disease Intervention/treatment Phase
Oral Cancer Drug: Metformin Hydrochloride 500 MG Drug: Placebo Oral Tablet Phase 3

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 62 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Cancer Chemoprevention by Metformin Hydrochloride Compared to Placebo in Oral Potentially Malignant Lesions: A Randomized Clinical Trial (Part 1)
Estimated Study Start Date : October 1, 2018
Estimated Primary Completion Date : September 30, 2019
Estimated Study Completion Date : September 30, 2020

Arm Intervention/treatment
Active Comparator: Metformin-Group
Metformin hydrochloride tablets 500 mg taken orally once daily for 3 months
Drug: Metformin Hydrochloride 500 MG
Metformin hydrochloride tablets 500 mg given orally once daily.
Other Names:
  • Glucophage
  • Cidophage

Placebo Comparator: Placebo-Group
Starch placebo tablets taken orally once daily for 3 months
Drug: Placebo Oral Tablet
Starch Placebo oral tablets will be given once daily to the control group

Primary Outcome Measures :
  1. Clinical Outcomes [ Time Frame: 3 months ]
    Effect of Systemic Metformin hydrochloride on the millimeters change in the largest diameter of the oral potentially malignant lesion

Secondary Outcome Measures :
  1. Immunohistochemical analysis [ Time Frame: 3 months ]
    Numerical change in immunohistochemical expression of Cyclin-D1 at baseline and at 3 months after using Metformin using computer aided image analysis

  2. microRNA analysis [ Time Frame: 3 months ]
    Numerical differences between miR-21 and miR-200 at baseline and at 3 months using Realtime PCR

  3. Salivary microRNA [ Time Frame: 3 months ]
    Numerical difference between the expression of miR-21 and miR-200 in tissue biopsies Versus Saliva at baseline and at 3 months

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 (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

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 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…

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03685409

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Faculty of Dentistry- Cairo University Recruiting
Cairo, Egypt
Contact: Fatheya M Zahran, Professor    00201060775113   
Contact: Gihan G Madkour, As.Prof.    00201121001005   
Sponsors and Collaborators
Cairo University

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Responsible Party: Ahmed Adel Mohamed Abdelazim, Assistant Lecturer, Cairo University Identifier: NCT03685409     History of Changes
Other Study ID Numbers: 023836530
First Posted: September 26, 2018    Key Record Dates
Last Update Posted: September 26, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Mouth Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Mouth Diseases
Stomatognathic Diseases
Hypoglycemic Agents
Physiological Effects of Drugs