Clinical Management Update of Oral Leukoplakia: A Review From the American Head and Neck Society Cancer Prevention Service.
James C Gates, Marianne Abouyared, Yelizaveta Shnayder...
https://pubmed.ncbi.nlm.nih.gov/39584361Actively Recruiting
Phase 2
Age: 18Years +
All Genders
ID05727761
Pioglitazone-Metformin Combination Treatment for High Risk Oral Preneoplasia
Led by University of Minnesota · Updated on 2025-12-24
36
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of a combination treatment of pioglitazone and metformin on high risk oral leukoplakia, a condition involving abnormal patches in the mouth that may develop into cancer. This Phase IIa study aims to understand the clinical and tissue-level changes in leukoplakia after a 12-week course of this oral medication. The study focuses on whether the treatment can reduce the severity of leukoplakia lesions and decrease cell proliferation markers. Participants will receive pioglitazone 15 mg and metformin 500 mg twice daily for 12 weeks. The study includes 36 patients with measurable high risk oral leukoplakia lesions, which must be accessible for biopsy. Researchers will perform biopsies before and after treatment to assess changes in the lesions and measure specific cell growth markers. The treatment is given orally and requires participants to follow the twice daily dosing schedule for the full 12 weeks. During the study, participants will undergo clinical exams and biopsies of the leukoplakia lesions at the start and end of the treatment period to assess changes. Researchers will measure clinical response, tissue changes, and Ki-67 cell proliferation levels. Participants must be able to comply with treatment and attend all visits. The study is expected to continue until July 2026, with careful monitoring of participant health and treatment adherence throughout the 12-week intervention.
CONDITIONS
Brief Title
Pioglitazone-Metformin Combination Treatment for High Risk Oral Preneoplasia
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Biopsy proven hyperplasia in high risk anatomic areas such as floor of mouth, mobile tongue, oropharynx
- Presence of hyperplasia or dysplasia of any grade in erythroplakia lesion
- Mild, moderate, or severe dysplasia within lesions in oral cavity or oropharynx
- Measurable oral leukoplakia lesions in 2 dimensions per RECIST, lesion must be accessible for punch biopsy and at least 4mm x 8mm
- Age 18 years or older
- Evidence of adequate organ function within 14 days prior to Day 1
- Ability to comply with treatment and complete 12 weeks of twice daily medication
- Body mass index (BMI) of 18.5 or greater
- Sexually active persons of child-bearing potential must use adequate contraception during study
- Provide voluntary written consent prior to research activities
You will not qualify if you...
- Pregnant, breastfeeding, or planning pregnancy
- Diagnosis of Type I or II diabetes treated with insulin or antidiabetic agents (diet/exercise controlled Type II diabetes allowed)
- Taking any other investigational agent not approved by the FDA
- History of allergic reaction to pioglitazone, metformin, or similar compounds
- Contraindication to biopsy procedure required by study
- History of bladder cancer including in situ
- History of invasive cancer (except non-melanoma skin or cervical cancer in situ) active within 18 months prior to baseline visit (curatively treated cancers without recurrence allowed)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 12 weeks
Participants take pioglitazone-metformin (15mg/500mg) twice a day for 12 weeks to treat high risk oral preneoplasia.
Visits may occur periodically during the 12 weeks for medication management and assessment
Trial Site Locations
Total: 2 locations
1
University of Minnesota
Minneapolis, Minnesota, United States, 55455
Actively Recruiting
2
HealthPartners
Saint Paul, Minnesota, United States, 55130
Actively Recruiting
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Research Team
B
Beverly Wuertz
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
PREVENTION
Number of Arms
1
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Published Research Related To This Trial
Safety of oral mucosal punch biopsy and other oral biospecimen collections in clinical research.
Aanish Puri, Beverly Wuertz, Nelson L Rhodus...
https://pubmed.ncbi.nlm.nih.gov/39532605