Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 5:06 AM
Ignite Modification Date:
2025-12-25 @ 5:06 AM
NCT ID:
NCT01440127
Eligibility Criteria:
Inclusion Criteria:
* Histologically documented colorectal cancer
* Intent to undergo disease resection or biopsy at least 7days from the treatment start date (allowing for a minimum of 5 days of treatment plus 2 days break)
* Medically fit for resection of their primary tumor or for biopsy
* Age 18-79 years
* Adequate renal function (serum creatinine levels \<1.5 mg/dL \[males\], \<1.4 mg/dL \[females\] or estimated creatinine clearance \>= 60 ml/min)
* Adequate hepatic parameters, including aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels ≤ 2.5 x upper limit of normal (ULN), total bilirubin ≤ 1.5 x ULN, and alkaline phosphatase levels ≤ 2.5 x ULN
* Ability to understand and willingness to sign a written informed consent document
Exclusion Criteria:
* Intent to administer neoadjuvant chemotherapy or radiation therapy prior to the surgery or biopsy;
* Intent to perform surgery or biopsy within 7 days of study treatment start;
* Any situation where participation in this trial would alter, or cause significant risk of altering the ability or timing of a subject to undergo resection of their tumor
* Current use of metformin (within the past month);
* Blood glucose using point of care test \< 70mg/dl;
* Renal disease or renal dysfunction not meeting inclusion criteria;
* Significant medical conditions such as cardiovascular collapse (shock), acute myocardial infarction, septicemia, acute or chronic metabolic acidosis
* History of, or states associated with, lactic acidosis such as shock or pulmonary insufficiency, alcoholism (acute or chronic), conditions associated with hypoxemia and pancreatitis
* Severe dehydration
* Clinical or laboratory evidence of hepatic disease
* Congestive heart failure requiring pharmacologic treatment, or unstable or acute congestive heart failure
* Known hypersensitivity to metformin hydrochloride
* Pregnant or lactating women
* Psychiatric illness or social situation that would limit compliance with study requirements and/or obscure results
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
79 Years
Study:
NCT01440127
Study Brief:
Protocol Section:
NCT01440127