Clinical trial · Interventional
Metformin for the Prevention of Oral Cancer in Patients With Oral Premalignant Lesions
Metformin Chemoprevention of Oral Premalignant Lesions
NCT05536037CI-TRIAL-00089748terminatedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Slow accrual
Summary
Brief summary (as posted)
This phase I trial tests whether metformin works in reducing the annual transformation (development of invasive cancer) of oral precancerous lesions into cancerous lesions. Metformin is a drug approved for the treatment of diabetes, but studies have shown that it may have some anticancer properties. Giving metformin may help prevent or slow the development of oral cancer from precancerous lesions.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Erythroplakia | — | UNRESOLVED | — |
| Leukoplakia | — | UNRESOLVED | — |
| Oral Cavity Carcinoma | Oral Cavity Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Proliferative Verrucous Leukoplakia | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Biopsy | Procedure | — | UNRESOLVED |
| Metformin | Drug | Metformin | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Prevention (metformin)
- description
- Patients receive metformin PO QD on days 1-3 and then PO BID for up to 12 months in the absence of unacceptable toxicity.
- interventionNames
- Drug: Metformin
- Procedure: Biopsy
Primary outcomes (1)
- measure
- Transformation-free-survival, in lesion types erythroplakia and verrucous hyperplasia
- timeFrame
- Up to 3 years
- description
- Will be summarized using Kaplan-Meier curves as well as 95% confidence ands. Kaplan-Meier estimates of the 3-year transformation-free-survival rates will be reported with 95% confidence interval. One-sample two-sided log-rank test will be applied to all four lesions as well.
Secondary outcomes (1)
- measure
- Change in lesion status
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria: * Age 18-85 * Clinical appearance of lesion * Homogenous leukoplakia * Non- homogenous leukoplakia * Erythroplakia * Proliferative verrucous leukoplakia * Histologic appearance * No dysplasia * Mild dysplasia * Moderate dysplasia * Severe dysplasia * Diabetics: if on metformin, will get them to 2000 mg per day, if not, will add metformin in consultation with endocrinologist * All subjects must be able to comprehend and sign a written informed consent document * Willing and able to be available for the duration of the study * In general good health with no contraindication to biopsy or metformin therapy * Laboratory results Exclusion Criteria: * Carcinoma in-situ, verrucous carcinoma, invasive squamous cell carcinoma (SCCa) * Exclude systemic causes of the lesion: pemphigus, pemphigoid, systemic lupus erythematosus (SLE), lichenoid drug reaction, human immunodeficiency virus (HIV), syphilis * Exclude local inciting factors: rule out (r/o) but allowing 2 weeks to pass and see if there is resolution, if not and doesn't resolve with local measures, medical treatment, enroll * Frictional: sharp tooth * Trauma * Immunosuppression by natural illness or medically induced * Hypersensitivity or allergic reaction to metformin or some other contraindication
References
Publications (0)
Data not yet available
No reference posted for this study.