Metformin for the Prevention of Oral Cancer in Patients With Oral Premalignant Lesions

  • End date
    Mar 20, 2025
  • participants needed
  • sponsor
    Thomas Jefferson University
Updated on 7 October 2022
precancerous lesions


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.



I. To evaluate the transformation-free-survival in lesion types erythroplakia (EP) and verrucous hyperplasia (VH).


I. To evaluate the current spontaneous regression rates, i.e., percentages of patients having lesion disappear within 1-year post treatment, in all four lesion types and compare them with historical documented regression rate in literature.


I. To evaluate the transformation-free-survival in lesion types homogenous leukoplakia (HL) and non-homogenous leukoplakia (NHL).


Patients receive metformin orally (PO) once daily (QD) on days 1-3 and then PO twice daily (BID) for up to 12 months in the absence of unacceptable toxicity.

After completion of study treatment, patients are followed up every 3 months for 24 months.

Condition Erythroplakia, Leukoplakia, Oral Cavity Carcinoma, Proliferative Verrucous Leukoplakia
Treatment biopsy, Metformin
Clinical Study IdentifierNCT05536037
SponsorThomas Jefferson University
Last Modified on7 October 2022


Yes No Not Sure

Inclusion Criteria

Age 18-85
Clinical appearance of lesion
Homogenous leukoplakia
Non- homogenous leukoplakia
Proliferative verrucous leukoplakia
Histologic appearance
No dysplasia
Mild dysplasia
Moderate 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

Severe dysplasia, 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
Immunosuppression by natural illness or medically induced
Hypersensitivity or allergic reaction to metformin or some other contraindication
Clear my responses

How to participate?

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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