NCT02083692

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P50-P75 for early_phase_1

Timeline
Completed

Started Sep 2013

Typical duration for early_phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 5, 2013

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 4, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 11, 2014

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 9, 2016

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 6, 2017

Completed
Last Updated

May 15, 2025

Status Verified

May 1, 2025

Enrollment Period

2.7 years

First QC Date

March 4, 2014

Last Update Submit

May 14, 2025

Conditions

Head and Neck Squamous Cell Cancer

Outcome Measures

Primary Outcomes (1)

  • Change in TOMM20 and MCT4 expression from tumor cells from date of biopsy and date of surgery

    date of biopsy and date of surgery (9-28 days)

Study Arms (1)

Metformin

EXPERIMENTAL
Drug: Metformin

Interventions

MetforminDRUG
Metformin

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of head and neck cancer biopsy proven, and who have a scheduled appointment for definitive resection of the tumor at TJUH
  • Age ≥ 18 years of age and ≤80 years old.
  • Newly diagnosed with HNSCC cancer.
  • No prior therapy for HNSCC cancer is permitted for enrollment in the trial.
  • All subjects must be able to comprehend and sign a written informed consent document.

You may not qualify if:

  • Pregnant or may become pregnant during metformin administration.
  • On metformin for any reason during the preceding 4 weeks.
  • Diabetic patients are eligible if they are not taking metformin, insulin or sulfonylureas.
  • Plasma alanine aminotransferase greater than 40 IU/dL.
  • Plasma aspartate aminotransferase greater than 45 IU/dL.
  • Plasma creatinine level greater than 1.3 mg/dL.
  • Plasma alkaline phosphatase greater than 190 IU/dL.
  • Plasma bicarbonate less than 22 mEq/L or history of lactic or any other metabolic acidosis.
  • History of congestive heart failure.
  • Myocardial ischemia or peripheral muscle ischemia.
  • Sepsis or severe infection.
  • History of lung disease currently requiring any pharmacologic or supplemental oxygen treatment.
  • Scheduled for definitive HNSCC cancer surgical resection less than two weeks from enrollment or greater than five weeks from enrollment.
  • History of hepatic dysfunction or hepatic disease.
  • Excessive alcohol intake which is defined in accordance with CDC definitions as more than 1 drink per day for women and more than 2 drinks per day for men.
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

Related Publications (3)

  • Crist M, Yaniv B, Palackdharry S, Lehn MA, Medvedovic M, Stone T, Gulati S, Karivedu V, Borchers M, Fuhrman B, Crago A, Curry J, Martinez-Outschoorn U, Takiar V, Wise-Draper TM. Metformin increases natural killer cell functions in head and neck squamous cell carcinoma through CXCL1 inhibition. J Immunother Cancer. 2022 Nov;10(11):e005632. doi: 10.1136/jitc-2022-005632.

    PMID: 36328378DERIVED

  • Amin D, Richa T, Mollaee M, Zhan T, Tassone P, Johnson J, Luginbuhl A, Cognetti D, Martinez-Outschoorn U, Stapp R, Solomides C, Rodeck U, Curry J. Metformin Effects on FOXP3+ and CD8+ T Cell Infiltrates of Head and Neck Squamous Cell Carcinoma. Laryngoscope. 2020 Sep;130(9):E490-E498. doi: 10.1002/lary.28336. Epub 2019 Oct 8.

    PMID: 31593308DERIVED

  • Curry J, Johnson J, Tassone P, Vidal MD, Menezes DW, Sprandio J, Mollaee M, Cotzia P, Birbe R, Lin Z, Gill K, Duddy E, Zhan T, Leiby B, Reyzer M, Cognetti D, Luginbuhl A, Tuluc M, Martinez-Outschoorn U. Metformin effects on head and neck squamous carcinoma microenvironment: Window of opportunity trial. Laryngoscope. 2017 Aug;127(8):1808-1815. doi: 10.1002/lary.26489. Epub 2017 Feb 10.

    PMID: 28185288DERIVED

Related Links

MeSH Terms

Interventions

Metformin

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic Chemicals

Study Officials

  • Joseph Curry, MD

    Thomas Jefferson University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 4, 2014

First Posted

March 11, 2014

Study Start

September 5, 2013

Primary Completion

May 9, 2016

Study Completion

April 6, 2017

Last Updated

May 15, 2025

Record last verified: 2025-05

Locations

US(1)