Last reviewed · How we verify

NCT02083692

Pilot Study of Metformin in Head and Neck Squamous Cell Cancer and Its Effects on Stromal-epithelial Metabolic Uncoupling

Completed EARLY_PHASE1 Last updated 15 May 2025
What this trial tests

EARLY_PHASE1 trial testing Metformin in Head and Neck Squamous Cell Cancer in 50 participants. Completed in 6 April 2017.

Timeline
5 September 2013
Primary endpoint
9 May 2016
6 April 2017

Quick facts

Lead sponsorSidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
PhaseEARLY_PHASE1
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposebasic science
Enrollment50
Start date5 September 2013
Primary completion9 May 2016
Estimated completion6 April 2017
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University

Who can join

Adults 18 to 80, any sex, with Head and Neck Squamous Cell Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The purpose of this study is to assess the effect of metformin in tumor metabolism in patients with head and neck cancer by evaluating metformin's ability to decrease TOMM20 expression in squamous carcinoma cells and decrease MCT4 expression in fibroblasts.

Publications & conference data

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

  1. Metabolism, metabolites, and macrophages in cancer.
    Li M, Yang Y, Xiong L, Jiang P, et al · · 2023 · cited 305× · PMID 37491279 · DOI 10.1186/s13045-023-01478-6
  2. Repurposing metformin for cancer treatment: current clinical studies.
    Chae YK, Arya A, Malecek MK, Shin DS, et al · · 2016 · cited 233× · PMID 27004404 · DOI 10.18632/oncotarget.8194
  3. Repurposing metformin for the prevention of cancer and cancer recurrence.
    Heckman-Stoddard BM, DeCensi A, Sahasrabuddhe VV, Ford LG. · · 2017 · cited 224× · PMID 28776080 · DOI 10.1007/s00125-017-4372-6
  4. Targeting hypoxic response for cancer therapy.
    Paolicchi E, Gemignani F, Krstic-Demonacos M, Dedhar S, et al · · 2016 · cited 73× · PMID 26859576 · DOI 10.18632/oncotarget.7229
  5. Dysregulations in the PI3K pathway and targeted therapies for head and neck squamous cell carcinoma.
    Cai Y, Dodhia S, Su GH. · · 2017 · cited 67× · PMID 28108737 · DOI 10.18632/oncotarget.14729
  6. Metformin increases natural killer cell functions in head and neck squamous cell carcinoma through CXCL1 inhibition.
    Crist M, Yaniv B, Palackdharry S, Lehn MA, et al · · 2022 · cited 61× · PMID 36328378 · DOI 10.1136/jitc-2022-005632
  7. Metformin effects on head and neck squamous carcinoma microenvironment: Window of opportunity trial.
    Curry J, Johnson J, Tassone P, Vidal MD, et al · · 2017 · cited 55× · PMID 28185288 · DOI 10.1002/lary.26489
  8. mTOR co-targeting strategies for head and neck cancer therapy.
    Wang Z, Valera JC, Zhao X, Chen Q, et al · · 2017 · cited 52× · PMID 28822012 · DOI 10.1007/s10555-017-9688-7

Verify or expand the search:

Other trials of Metformin

Trials testing the same drug.

Other recruiting trials for Head and Neck Squamous Cell Cancer

Currently open trials in the same condition.

Other Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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/NCT02083692.

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