NCT03684707

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Sep 2018

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 15, 2018

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

September 20, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 26, 2018

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2019

Completed
Last Updated

September 26, 2018

Status Verified

September 1, 2018

Enrollment Period

9 months

First QC Date

September 20, 2018

Last Update Submit

September 24, 2018

Conditions

Oral Cancer

Outcome Measures

Primary Outcomes (1)

  • Evaluate lesion size in millimeters

    Evaluate lesion size in millimeters

    1 year

Secondary Outcomes (2)

  • Measurement of salivary Micro RNA

    1 year

  • Measuring immuno-histochemical marker

    1 year

Study Arms (2)

Metformin Hcl 500Mg 24Hr Sa Tab

ACTIVE COMPARATOR

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

Drug: Metformin Hcl 500Mg 24Hr Sa Tab

control

PLACEBO COMPARATOR

starch tablets

Other: starch tablet

Interventions

Metformin Hcl 500Mg 24Hr Sa TabDRUG

Glucophage 500 mg once daily

Also known as: Glucophage
Metformin Hcl 500Mg 24Hr Sa Tab
starch tabletOTHER

starch tablets

control

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • \- 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…

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Noha Nasr

Cairo, New Cairo, 11835, Egypt

RECRUITING

MeSH Terms

Conditions

Mouth Neoplasms

Interventions

MetforminStarch

Condition Hierarchy (Ancestors)

Head and Neck NeoplasmsNeoplasms by SiteNeoplasmsMouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic ChemicalsGlucansBiopolymersPolymersMacromolecular SubstancesDietary CarbohydratesCarbohydratesPolysaccharides

Study Officials

  • Fathia Z. Zahran, PHD

    Cairo University

    STUDY CHAIR

Central Study Contacts

Noha N. El-Zalabany, Masters

CONTACT

01005365769noha_nasr84@yahoo.com

Ahmed A. Abd El-Azim, Masters

CONTACT

01007975679hero_ahmed704@hotmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Randomized clinical trials
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Lecturer

Study Record Dates

First Submitted

September 20, 2018

First Posted

September 26, 2018

Study Start

September 15, 2018

Primary Completion

June 15, 2019

Study Completion

September 15, 2019

Last Updated

September 26, 2018

Record last verified: 2018-09

Locations

EG(1)