Nitric Oxide-Releasing Acetylsalicyclic Acid in Preventing Colorectal Cancer in Patients at High Risk of Colorectal Cancer
Colorectal Cancer
About this trial
This is an interventional prevention trial for Colorectal Cancer focused on measuring colon cancer, rectal cancer
Eligibility Criteria
DISEASE CHARACTERISTICS: At risk for colorectal cancer History of histologically proven sporadic colon adenomas or colon cancer At least 5 aberrant cryptic foci on sigmoidoscopy Less than 20 prior cumulative adenomas and no heredity nonpolyposis colorectal cancer No significant asymptomatic lesions on sigmoidoscopy, including any of the following: Inflammation Strictures Anorectal lesions Fistulae Vascular lesions No adenomas or colon carcinomas on flexible sigmoidoscopy No history of gastrointestinal (GI) cancer other than colorectal cancer No inherited colorectal cancer syndromes PATIENT CHARACTERISTICS: No other GI mucosal epithelial diseases (e.g., Barrett's esophagus, chronic or recurrent peptic ulcer disease, celiac sprue, or other disorders of nutrient absorption) No active peptic ulcer disease No history of inflammatory bowel disease (ulcerative colitis or Crohn's disease) No known or suspected alcohol ( > 5 glasses of wine or beer per day), drug, or medication abuse No quantitative or qualitative platelet or coagulation abnormalities No personal or family history of a bleeding disorder No uncontrolled diabetes No uncontrolled hypertension, or chronic congestive heart failure (New York Heart Association class II-IV heart disease) No myocardial infarction, transient ischemic attack, or stroke within the past 6 months No equilibrium disorders affecting gait or ability to stand that would preclude study participation No involuntary change in weight (up or down) of ≥ 15% of usual body weight within the past year Creatinine ≤ 2.0 mg/dL No chronic liver disease or pancreatitis No allergies to aspirin No prior severe adverse reactions to NSAIDs such as asthma, GI bleeding, or renal insufficiency No institutionalized, mentally disabled patients No prisoners Not pregnant or nursing Fertile patients must use effective contraception Negative pregnancy test PRIOR CONCURRENT THERAPY: No concurrent antibiotic prophylaxis More than 7 days since prior nonsteroidal anti-inflammatory drug (NSAID) treatment, including aspirin No concurrent frequent use (> 7 days in previous month) of NSAIDs, cyclooxygenase (COX)-2 inhibitors, nitrovasodilators, or oral corticosteroids No concurrent macronutrient consumption below the 1st or above the 99th percentile of U.S. consumption No concurrent anticoagulants, ticlopidine, and clopidogrel More than 3 months since prior general anesthesia More than 3 months since prior investigational agents No concurrent NSAIDs, including aspirin or COX-2 inhibitors Acetaminophen allowed No concurrent nitrovasodilating drugs More than 3 months since prior participation in other investigational trials
Sites / Locations
- Stony Brook University Cancer Center