NCT05536037 is a Phase 1 clinical trial of Metformin in Erythroplakia, sponsored by Thomas Jefferson University.

Who is sponsoring NCT05536037?

NCT05536037 is sponsored by Thomas Jefferson University.

What drugs are being tested in NCT05536037?

Interventions in NCT05536037: Metformin, Biopsy.

What condition does NCT05536037 study?

NCT05536037 studies Erythroplakia, Leukoplakia, Oral Cavity Carcinoma, Proliferative Verrucous Leukoplakia.

Is NCT05536037 still recruiting?

NCT05536037 is currently terminated. Last updated 15 May 2025.

Last reviewed 2025-05-15 · How we verify

NCT05536037

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Terminated Phase 1 Last updated 15 May 2025

What this trial tests

Phase 1 trial testing Metformin in Erythroplakia in 4 participants. Terminated before completion.

Timeline

4 May 2022

Primary endpoint
16 March 2024

16 March 2024

Quick facts

Lead sponsor	Thomas Jefferson University
Phase	Phase 1
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	prevention
Enrollment	4
Start date	4 May 2022
Primary completion	16 March 2024
Estimated completion	16 March 2024
Sites	1 location across United States

Drugs / interventions tested

Metformin (metformin) — full drug profile →
Biopsy — full drug profile →

Conditions studied

Erythroplakia — all drugs for Erythroplakia →
Leukoplakia — all drugs for Leukoplakia →
Oral Cavity Carcinoma — all drugs for Oral Cavity Carcinoma →
Proliferative Verrucous Leukoplakia — all drugs for Proliferative Verrucous Leukoplakia →

Sponsor

Thomas Jefferson University

Who can join

Adults 18 to 85, any sex, with Erythroplakia or Leukoplakia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

Tumor initiation and early tumorigenesis: molecular mechanisms and interventional targets.
Zhang S, Xiao X, Yi Y, Wang X, et al · · 2024 · cited 192× · PMID 38890350 · DOI 10.1038/s41392-024-01848-7
Immunometabolism in cancer: basic mechanisms and new targeting strategy.
Su R, Shao Y, Huang M, Liu D, et al · · 2024 · cited 28× · PMID 38755125 · DOI 10.1038/s41420-024-02006-2
Randomized Study of Metformin and Intensive Lifestyle Intervention on Cancer Incidence over 21 Years of Follow-up in the Diabetes Prevention Program.
Heckman-Stoddard BM, Crandall JP, Edelstein SL, Prorok PC, et al · · 2025 · cited 4× · PMID 40243198 · DOI 10.1158/1940-6207.capr-23-0461
Chemoprevention of Head and Neck Cancer: A Review of Current Approaches and Future Perspectives.
Han S, Bommireddy R, Kim P, Selvaraj P, et al · · 2024 · cited 3× · PMID 38978394 · DOI 10.1158/1940-6207.capr-24-0093

Verify or expand the search:

Other trials of Metformin

Trials testing the same drug.

NCT07275359 — Investigating Senolytic Properties in Pulmonary Rehabilitation and Metformin in COPD Exacerbations · Phase 1 · not yet recruiting
NCT07520110 — Metformin to Attenuate Progressive Respiratory Decline in Idiopathic Pulmonary Fibrosis · Phase 3 · not yet recruiting
NCT07007221 — Clinical Trials to Evaluate Metformin to Treat Depression in People Living With HIV · Phase 2 · not yet recruiting
NCT07585396 — Inositol in Letrozol Resistant PCOS Women · Phase 2, PHASE3 · not yet recruiting
NCT07226453 — Target Validation and Efficacy of Metformin in Patients With Posterior Fossa Group A (PFA) Ependymoma · Phase 2 · not yet recruiting

Other recruiting trials for Erythroplakia

Currently open trials in the same condition.

NCT02581137 — Metformin Hydrochloride in Preventing Oral Cancer in Patients With an Oral Premalignant Lesion · Phase 2 · active not recruiting
NCT00542373 — Widefield Fluorescence and Reflectance Imaging Systems and Oral Tissue Samples in Monitoring Participants at Risk for De · NA · active not recruiting

Other Thomas Jefferson University trials

Trials by the same sponsor.

NCT07526480 — Improving Dementia Care in Primary Practice · NA · not yet recruiting
NCT07414550 — Radiotherapy for Refractory Hidradenitis Suppurativa · NA · not yet recruiting
NCT07402018 — Intra-aortic Balloon Counterpulsation (IABC) Compliance · recruiting
NCT07217197 — Respiratory Monitoring System That Detects & Predicts OIRD · NA · enrolling by invitation
NCT07145099 — The IMPACT Study: Personalized Physical Therapy for Better Recovery and a Stronger Core After Hernia Surgery · NA · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05536037 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Thomas Jefferson University
Last refreshed: 15 May 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05536037.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing