Sulindac and Plant Compounds in Preventing Colon Cancer
Colorectal Cancer
About this trial
This is an interventional prevention trial for Colorectal Cancer focused on measuring colon cancer
Eligibility Criteria
DISEASE CHARACTERISTICS: Individuals at average risk (Parts A and B) or above average risk (Part A only) for development of colon cancer Average risk individuals defined as: No history of colon adenomas No strong family history of colon polyps or cancer Above average risk individuals defined as: History of one or more sporadic adenomatous polyps at least 0.5 cm in size (either tubular, tubulovillous, or villous adenomas) Have had polypectomy or refused this procedure No significant family history of adenomatous polyps, colon cancer, or hereditary nonpolyposis colorectal cancer or other hereditary colon cancer syndrome Polyps should not have had a focus of adenocarcinoma within them No history of gastrointestinal cancer outside of the large bowel No other gastrointestinal mucosal epithelial disease (e.g., Barrett's esophagus, chronic or recurrent peptic ulcer disease, celiac sprue, or other disorders of nutrient absorption) No significant asymptomatic lesions on flexible sigmoidoscopy, such as inflammation, premalignancy or malignancy PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Not specified Life expectancy: Not specified Hematopoietic: No platelet or coagulation abnormalities No personal or family history of a bleeding disorder Hematopoietic concentration must not be due to significant acute or chronic disorder Hepatic: No liver disease Renal: No renal insufficiency Cardiovascular: No uncontrolled hypertension No chronic congestive heart failure No history of endocarditis No history of rheumatic fever No cardiac valve prostheses No mitral valve prolapse that requires antibiotic prophylaxis Other: HIV negative No gout No pancreatitis No other chronic viral infection No significant acute or uncontrolled chronic medical illness Generally non-smoking (no more than 4 cigarettes per week, i.e., not daily smokers) Must abstain from smoking for at least 1 month prior to enrolling in the study No alcohol consumption of greater than 2 glasses of wine or beer per day Normal weight (90-120% of optimum body weight) and body habitus No change in weight within 5-10% of body weight within the past year No history of inflammatory bowel disease (either ulcerative colitis or Crohn's disease ) No hearing or equilibrium disorders No other prior malignancy except resected carcinoma in situ of the cervix or nonmelanoma skin cancer No allergies to sulindac or tartrazine dyes or prior severe adverse reactions to nonsteroidal antiinflammatory drugs (asthma, gastrointestinal bleeding, or renal insufficiency) No potential allergy to curcumin, quercetin, or rutin No gastrointestinal bleeding Not institutionalized, mentally disabled, or incarcerated No unusually high intake of stored micronutrients or high doses of supplemental calcium or folate Not pregnant or nursing PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Not specified Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified Other: No concurrent coumadin No chronic use of nonsteroidal antiinflammatory drugs (unless they can be stopped for 3 months) No other putative colon cancer chemoprevention agents (unless they can be stopped for 3 months)
Sites / Locations
- Rockefeller University Hospital