Sulindac and Plant Compounds in Preventing Colon Cancer

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)