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

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

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03684707
Enrollment
30
Registered
2018-09-26
Start date
2018-09-15
Completion date
2019-09-15
Last updated
2018-09-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Oral Cancer

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.

Interventions

DRUGMetformin Hcl 500Mg 24Hr Sa Tab

Glucophage 500 mg once daily

OTHERstarch tablet

starch tablets

Sponsors

Ain Shams University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Intervention model description

Randomized clinical trials

Eligibility

Sex/Gender
ALL
Age
20 Years to 60 Years
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. * 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…

Design outcomes

Primary

MeasureTime frameDescription
Evaluate lesion size in millimeters1 yearEvaluate lesion size in millimeters

Secondary

MeasureTime frameDescription
Measurement of salivary Micro RNA1 yearmeasuring salivary markers 31& 210 in saliva and also in tissue biopsy
Measuring immuno-histochemical marker1 yearMeasuring cyclin A2 marker in tissues

Countries

Egypt

Contacts

Primary ContactNoha N. El-Zalabany, Masters
noha_nasr84@yahoo.com01005365769
Backup ContactAhmed A. Abd El-Azim, Masters
hero_ahmed704@hotmail.com01007975679

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026