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This study evaluates the effect of the drug Metformin on the oxygenation of tumor tissue in patients with oral cavity squamous cell carcinoma. It enrolled newly diagnosed, previously untreated patients over 18 who were scheduled for tumor resection surgery. This was a non-phase study and has been completed.
The summary above is a plain-language rendering of the official record. The original English title is shown for reference.
Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.
Inclusion Criteria: * Patients with biopsy-proven oral cavity squamous cell carcinoma, planned for tumor resection upon institutional tumor board decision. * Tumor tissue (biopsy) prior to metformin administration available for genetic testing * Age ≥ 18 years of age. * First diagnosis, no prior treatment. * All subjects must be able to comprehend and sign a written informed consent document. * Informed consent as documented by signature Exclusion Criteria: * Pregnancy or lactation. * Distant metastasis. * Hypersensitivity to metformin or any of its components. * Metformin treatment for any reason during the preceding 3 months. * Diabetic patients regardless of treatment. * Patients planned for imaging using iodinated contrast dye within 16 days prior to surgery. * Any concomitant drug contraindicated for use with metformin according to the approved product information. * Plasma alanine aminotransferase \> 50 IU/dL. * Plasma aspartate aminotransferase \> 50 IU/dL. * Estimated glomerular filtration rate (eGFR) \<60 ml/min/1.73m2. * Plasma alkaline phosphatase greater than 190 IU/dL. * History of lactic or any other metabolic acidosis. * History of diseases potentially causing tissue hypoxia and/or increased risk of lactic acidosis: * Congestive heart failure. * Myocardial ischemia within the last 6 months * Sepsis or severe infection. * History of lung disease currently requiring any pharmacologic or supplemental oxygen treatment. * History of hepatic dysfunction or hepatic disease. * Chronic alcoholism which poses a risk for acute alcohol intoxication at the discretion of the treating physician. * Scheduled definitive surgical resection less than 10 days from enrollment. * Any other serious underlying medical, psychiatric, psychological, familial or geographical condition, which in the judgment of the investigator may interfere with the planned staging, treatment, affect patient compliance or place the patient at high risk from treatment-related complication * Known or suspected non-compliance. * Participation in another study with investigational drug within the 30 days preceding and during the present study.