Metformin for the Prevention of Oral Cancer in Patients With Oral Premalignant Lesions
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- STATUS
- Recruiting
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- End date
- Mar 20, 2025
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- participants needed
- 116
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- sponsor
- Thomas Jefferson University
Summary
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.
Description
PRIMARY OBJECTIVE:
I. To evaluate the transformation-free-survival in lesion types erythroplakia (EP) and verrucous hyperplasia (VH).
SECONDARY OBJECTIVE:
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.
EXPLORATORY OBJECTIVE:
I. To evaluate the transformation-free-survival in lesion types homogenous leukoplakia (HL) and non-homogenous leukoplakia (NHL).
- OUTLINE
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.
Details
| Condition | Erythroplakia, Leukoplakia, Oral Cavity Carcinoma, Proliferative Verrucous Leukoplakia |
|---|---|
| Treatment | biopsy, Metformin |
| Clinical Study Identifier | NCT05536037 |
| Sponsor | Thomas Jefferson University |
| Last Modified on | 7 October 2022 |
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