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Cancer Chemoprevention by Metformin Hydrochloride Compared to Placebo 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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03684707
Recruitment Status : Unknown
Verified September 2018 by Noha Nasr, Ain Shams University.
Recruitment status was:  Recruiting
First Posted : September 26, 2018
Last Update Posted : September 26, 2018
Sponsor:
Information provided by (Responsible Party):
Noha Nasr, Ain Shams University

Study Description
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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.


Condition or disease Intervention/treatment Phase
Oral Cancer Drug: Metformin Hcl 500Mg 24Hr Sa Tab Other: starch tablet Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized clinical trials
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Cancer Chemoprevention by Metformin Hydrochloride Compared to Placebo in Oral Potentially Malignant Lesions: A Randomised Clinical Trial
Actual Study Start Date : September 15, 2018
Estimated Primary Completion Date : June 15, 2019
Estimated Study Completion Date : September 15, 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Metformin Hcl 500Mg 24Hr Sa Tab
Metformin Hcl 500Mg 24Hr Sa Tab drug is given to the patient
 Drug: Metformin Hcl 500Mg 24Hr Sa Tab
Glucophage 500 mg once daily
Other Name: Glucophage
Placebo Comparator: control
starch tablets
 Other: starch tablet
starch tablets


Outcome Measures
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Primary Outcome Measures :
  1. Evaluate lesion size in millimeters [ Time Frame: 1 year ]
    Evaluate lesion size in millimeters


Secondary Outcome Measures :
  1. Measurement of salivary Micro RNA [ Time Frame: 1 year ]
    measuring salivary markers 31& 210 in saliva and also in tissue biopsy

  2. Measuring immuno-histochemical marker [ Time Frame: 1 year ]
    Measuring cyclin A2 marker in tissues


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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…
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT03684707


Contacts
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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

Locations
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Egypt
Noha Nasr Recruiting
Cairo, New Cairo, Egypt, 11835
Contact: Noha N. El-Zalabany, Masters    1005365769 ext 02    noha_nasr84@yahoo.com   
Contact: Noha N. El-Zalabany, Masters    01005365769 ext 02    noha_nasr84@yahoo.com   
Sponsors and Collaborators
Ain Shams University
Investigators
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Study Chair: Fathia Z. Zahran, PHD Cairo University
More Information
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Responsible Party: Noha Nasr, Assistant Lecturer, Ain Shams University
ClinicalTrials.gov Identifier: NCT03684707    
Other Study ID Numbers: Cairo University
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: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Mouth Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms
Mouth Diseases
 Stomatognathic Diseases
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs