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

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ClinicalTrials.gov Identifier: NCT03684707
Recruitment Status : Recruiting
First Posted : September 26, 2018
Last Update Posted : September 26, 2018
Sponsor:
Information provided by (Responsible Party):
Noha Nasr, Ain Shams University

Tracking Information
First Submitted Date  ICMJE September 20, 2018
First Posted Date  ICMJE September 26, 2018
Last Update Posted Date September 26, 2018
Actual Study Start Date  ICMJE September 15, 2018
Estimated Primary Completion Date June 15, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 24, 2018)
Evaluate lesion size in millimeters [ Time Frame: 1 year ]
Evaluate lesion size in millimeters
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: September 24, 2018)
  • Measurement of salivary Micro RNA [ Time Frame: 1 year ]
    measuring salivary markers 31& 210 in saliva and also in tissue biopsy
  • Measuring immuno-histochemical marker [ Time Frame: 1 year ]
    Measuring cyclin A2 marker in tissues
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Cancer Chemoprevention by Metformin Hydrochloride Compared to Placebo in Oral Potentially Malignant Lesions
Official Title  ICMJE 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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Randomized clinical trials
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Oral Cancer
Intervention  ICMJE
  • Drug: Metformin Hcl 500Mg 24Hr Sa Tab
    Glucophage 500 mg once daily
    Other Name: Glucophage
  • Other: starch tablet
    starch tablets
Study Arms  ICMJE
  • Active Comparator: Metformin Hcl 500Mg 24Hr Sa Tab
    Metformin Hcl 500Mg 24Hr Sa Tab drug is given to the patient
    Intervention: Drug: Metformin Hcl 500Mg 24Hr Sa Tab
  • Placebo Comparator: control
    starch tablets
    Intervention: Other: starch tablet
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 24, 2018)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 15, 2019
Estimated Primary Completion Date June 15, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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…
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Noha N. El-Zalabany, Masters 01005365769 ext 02 noha_nasr84@yahoo.com
Contact: Ahmed A. Abd El-Azim, Masters 01007975679 ext 02 hero_ahmed704@hotmail.com
Listed Location Countries  ICMJE Egypt
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03684707
Other Study ID Numbers  ICMJE Cairo University
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Noha Nasr, Ain Shams University
Study Sponsor  ICMJE Ain Shams University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Fathia Z. Zahran, PHD Cairo University
PRS Account Ain Shams University
Verification Date September 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP