Oral Cavity Carcinoma Clinical Trial
Official title:
Metformin Chemoprevention of Oral Premalignant Lesions
NCT number | NCT05536037 |
Other study ID # | 22D.296 |
Secondary ID | |
Status | Terminated |
Phase | Phase 1 |
First received | |
Last updated | |
Start date | May 4, 2022 |
Est. completion date | March 16, 2024 |
Verified date | April 2024 |
Source | Thomas Jefferson University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 4 |
Est. completion date | March 16, 2024 |
Est. primary completion date | March 16, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 85 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Thomas Jefferson University Hospital | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Thomas Jefferson University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Transformation-free-survival, in lesion types homogenous leukoplakia and non-homogenous leukoplakia | 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. | Up to 3 years | |
Primary | Transformation-free-survival, in lesion types erythroplakia and verrucous hyperplasia | 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. | Up to 3 years | |
Secondary | Change in lesion status | Evaluated on a Likert-scale with three levels: 'worsen', 'same' and 'disappear', compared to each patient's baseline lesion status (as measured at pre-treatment and one year post initiation of treatment). The lesion size and status evaluated at 1-year post-treatment will be summarized using percentages as well as 95% Clopper-Pearson exact confidence intervals. The current spontaneous regression rates (i.e., percentage of 'disappear') will be compared against the historically documented regression rate of 35% using two-sided exact binomial test. | Baseline to 1 year after treatment |
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