Clinical trial · Interventional
Sulindac and Plant Compounds in Preventing Colon Cancer
The Effect of Plant Phenolic Compounds on Human Colon Epithelial Cells
NCT00003365CI-TRIAL-00004362terminatedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Study completed
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| curcumin | Dietary Supplement | — | UNRESOLVED |
| quercetin | Drug | — | UNRESOLVED |
| rutin | Dietary Supplement | — | UNRESOLVED |
| sulindac | Drug | Sulindac | ALIAS |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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)References
Publications (0)
Data not yet available
No reference posted for this study.