Clinical trial · Interventional
Cancer Chemoprevention by Metformin Hydrochloride in Oral Potentially Malignant Lesions
Cancer Chemoprevention by Metformin Hydrochloride Compared to Placebo in Oral Potentially Malignant Lesions: A Randomized Clinical Trial (Part 1)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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 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. Metformin, one of most widely prescribed oral hypoglycemic agents, has recently received increased attention because of its potential anti-tumorigenic effects that are thought to be independent of its hypoglycemic effects. Evans et al. first found an association between metformin use and decreased cancer incidence. The study will reveal whether Systemic Metformin hydrochloride treatment given to patients with oral potentially malignant lesions improve the prognosis and prevent or at least reduce the incidence of malignant transformation?
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Oral Cancer | Malignant Lip and Oral Cavity Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Metformin Hydrochloride 500 MG | Drug | Metformin | ALIAS |
| Placebo Oral Tablet | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Metformin-Group
- description
- Metformin hydrochloride tablets 500 mg taken orally once daily for 3 months
- interventionNames
- Drug: Metformin Hydrochloride 500 MG
- type
- PLACEBO_COMPARATOR
- label
- Placebo-Group
- description
- Starch placebo tablets taken orally once daily for 3 months
- interventionNames
- Drug: Placebo Oral Tablet
Primary outcomes (1)
- measure
- Clinical Outcomes
- timeFrame
- 3 months
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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 (Atrophic oral lichen planus, leukoplakia, erythroplakia and oral submucous fibrosis). * 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 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 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…
References
Publications (0)
Data not yet available