Sulindac and Plant Compounds in Preventing Colon Cancer

NCT00003365 | Terminated

• 5 other identifiers: CDR0000066350P30CA016056RUH-SSH-190-0600RUH-SSH-190-0698NCI-V98-1425
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. The use of sulindac may be an effective way to prevent colon cancer. Eating a diet rich in fruits and vegetables appears to reduce the risk of some types of cancer. Curcumin, rutin, and quercetin are compounds found in plants that may prevent the development of colon cancer. PURPOSE: Randomized clinical trial to study the effectiveness of sulindac, curcumin, rutin, and quercetin in preventing colon cancer.

Conditions

Colorectal Cancer

Keywords

colon cancer

Interventions

curcumin DIETARY_SUPPLEMENT

rutin DIETARY_SUPPLEMENT

quercetin DRUG

sulindac DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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)

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of Medicine and Dentistry of New Jersey: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Rockefeller University Hospital

New York, New York, 10021-6399, United States

Location

MeSH Terms

Conditions

Colorectal Neoplasms; Colonic Neoplasms

Interventions

Curcumin; Rutin; Quercetin; Sulindac

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Diarylheptanoids; Heptanes; Alkanes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Flavonols; Flavonoids; Chromones; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Steven J. Shiff, MD

  Rutgers Cancer Institute of New Jersey

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Purpose: PREVENTION
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: May 21, 2004
• Study Start: August 1, 1996
• Primary Completion: July 1, 2006
• Study Completion: July 1, 2006
• Last Updated: January 27, 2011

Record last verified: 2011-01

Locations

US (1)