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

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

Status
Completed
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02083692
Enrollment
50
Registered
2014-03-11
Start date
2013-09-05
Completion date
2017-04-06
Last updated
2025-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Head and Neck Squamous Cell Cancer

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.

Interventions

DRUGMetformin

Sponsors

Sidney Kimmel Cancer Center at Thomas Jefferson University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* 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.

Exclusion criteria

* 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. * Received iodinated contrast dye less than 48 hours prior to screening meet a temporary

Design outcomes

Primary

MeasureTime frame
Change in TOMM20 and MCT4 expression from tumor cells from date of biopsy and date of surgerydate of biopsy and date of surgery (9-28 days)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026