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

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Brief Title

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

Official Title

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

Brief 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.
    

Study Phase

Phase 4

Study Type

Interventional


Primary Outcome

Evaluate lesion size in millimeters

Secondary Outcome

 Measurement of salivary Micro RNA

Condition

Oral Cancer

Intervention

Metformin Hcl 500Mg 24Hr Sa Tab

Study Arms / Comparison Groups

 Metformin Hcl 500Mg 24Hr Sa Tab
Description:  Metformin Hcl 500Mg 24Hr Sa Tab drug is given to the patient

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

30

Start Date

September 15, 2018

Completion Date

September 15, 2019

Primary Completion Date

June 15, 2019

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…
      

Gender

All

Ages

20 Years - 60 Years

Accepts Healthy Volunteers

No

Contacts

Fathia Z. Zahran, PHD, 01005365769, [email protected]

Location Countries

Egypt

Location Countries

Egypt

Administrative Informations


NCT ID

NCT03684707

Organization ID

Cairo University


Responsible Party

Principal Investigator

Study Sponsor

Ain Shams University


Study Sponsor

Fathia Z. Zahran, PHD, Study Chair, Cairo University


Verification Date

September 2018