Metformin Hydrochloride in Reducing Metabolic Activity of Cancer Cells in Patients with Head and Neck Squamous Cell Cancer

Inclusion Criteria

• Subjects with a diagnosis of head and neck cancer biopsy proven, and who have a scheduled appointment for definitive resection of the tumor at Thomas Jefferson University Hospital (TJUH) are eligible to participate
• All subjects must be able to comprehend and sign a written informed consent document

Exclusion Criteria

• Subjects who are pregnant or may become pregnant during metformin administration
• Subjects on metformin for any reason during the preceding 4 weeks
• Diabetic subjects are eligible if they are not taking metformin, insulin or sulfonylureas
• Subjects who have received iodinated contrast dye less than 48 hours prior to screening meet a temporary exclusion criteria to receive metformin; these patients cannot start investigational metformin until 48 hours have elapsed from contrast administration; subjects who are scheduled for iodinated contrast dye administration within 48 hours of definitive surgery are excluded
• Patients with plasma creatinine level greater than 1.3 mg/dL
• Patients with plasma bicarbonate less than 22 mEq/L or history of lactic or any other metabolic acidosis
• Patients with history of congestive heart failure
• Patients with myocardial ischemia or peripheral muscle ischemia
• Patients with sepsis or severe infection
• Patients with history of lung disease currently requiring any pharmacologic or supplemental oxygen treatment
• Patients scheduled for definitive head and neck squamous cell carcinoma (HNSCC) cancer surgical resection less than 9 days from enrollment or greater than five weeks from enrollment
• Patients with history of hepatic dysfunction or hepatic disease and abnormal liver function tests; patients who have a history of hepatic dysfunction or hepatic disease and normal liver function tests will be eligible to participate
• Patients with a history of excessive alcohol intake which is defined in accordance with Centers for Disease Control and Prevention (CDC) definitions as more than 1 drink per day for women and more than 2 drinks per day for men