Metformin for Leukoplakia

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Thomas Jefferson University Hospital, Philadelphia, PA
Leukoplakia+5 More
Metformin - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study 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.

Eligible Conditions

  • Proliferative Verrucous Leukoplakia
  • Leukoplakia
  • Erythroplakia
  • Oral Cavity Carcinoma

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 1 Secondary · Reporting Duration: Up to 3 years

Year 1
Change in lesion status
Up to 3 years
Transformation-free-survival, in lesion types erythroplakia and verrucous hyperplasia
Transformation-free-survival, in lesion types homogenous leukoplakia and non-homogenous leukoplakia

Trial Safety

Safety Progress

1 of 3

Trial Design

1 Treatment Group

Prevention (metformin)
1 of 1
Experimental Treatment

116 Total Participants · 1 Treatment Group

Primary Treatment: Metformin · No Placebo Group · Phase 1

Prevention (metformin)Experimental Group · 2 Interventions: Biopsy, Metformin · Intervention Types: Procedure, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Biopsy
2014
Completed Phase 4
~1120
Metformin
2006
Completed Phase 4
~2480

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 3 years
Closest Location: Thomas Jefferson University Hospital · Philadelphia, PA
Photo of Philadelphia 1Photo of Philadelphia 2Photo of Philadelphia 3
2004First Recorded Clinical Trial
1 TrialsResearching Leukoplakia
241 CompletedClinical Trials

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
12,930 Previous Clinical Trials
41,294,344 Total Patients Enrolled
12 Trials studying Leukoplakia
1,055 Patients Enrolled for Leukoplakia
Thomas Jefferson UniversityLead Sponsor
393 Previous Clinical Trials
126,357 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have a clinical appearance of lesion that is typical of a mycobacterial infection.
You have non-homogenous leukoplakia.
Patients aged 18-85 years old.\n
You have homogenous leukoplakia.
Proliferative verrucous leukoplakia is a condition that causes wart-like growths on the lips.
You have no dysplasia.
You have moderate dysplasia.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.