- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00003365
Sulindac and Plant Compounds in Preventing Colon Cancer
The Effect of Plant Phenolic Compounds on Human Colon Epithelial Cells
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
OBJECTIVES:
- Determine the response of the colonic epithelium in normal volunteers at average or above average risk of colon cancer, when given short term treatment with plant phenolics such as curcumin, rutin, and quercetin.
- Compare the colonic mucosal response to the plant phenolics with their response to sulindac in order to evaluate whether they share common mechanisms for colon cancer chemoprevention.
- Determine the lowest optimal dose for each of the three plant phenolics that is effective in modulating biomarkers of colon epithelial cell turnover and, therefore, potentially inhibiting colon cancer development.
- Assess the response of the colonic epithelium to curcumin in volunteers at average risk of colon cancer development.
OUTLINE: This is a randomized, controlled, two part, single institution study. Patients in Part B are randomized by gender.
All patients undergo flexible sigmoidoscopic exam.
- Part A: Patients, in cohorts of 5-10, receive one of the following five treatments in addition to the control diet: nothing (arm I), oral sulindac twice a day (arm II), oral rutin at 1 of 3 doses twice a day (arms III, IV, and V), oral quercetin at 1 of 3 doses twice a day (arms V, VI, and VII), or at 1 of 3 doses oral curcumin twice a day (arms VIII, IX, and X). Patients are first randomized to the highest doses of rutin, quercetin, and curcumin and then lower doses may be given in order to determine the minimally effective dose. Treatment is continued for 6-10 weeks.
- Part B: Patients are randomized to receive the control diet only (arm I) or the control diet plus oral curcumin twice a day (arm II) for 6-10 weeks.
Patients are followed every 2 weeks.
PROJECTED ACCRUAL: There will be 130 patients (110 in Part A and 20 in Part B) accrued into this study.
Study Type
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
New York
-
New York, New York, United States, 10021-6399
- Rockefeller University Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
Collaborators and Investigators
Collaborators
Investigators
- Study Chair: Steven J. Shiff, MD, Rutgers Cancer Institute of New Jersey
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms
- Neoplasms by Site
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Colonic Diseases
- Intestinal Diseases
- Intestinal Neoplasms
- Rectal Diseases
- Colorectal Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Cyclooxygenase Inhibitors
- Antineoplastic Agents
- Protective Agents
- Antioxidants
- Quercetin
- Curcumin
- Sulindac
Other Study ID Numbers
- CDR0000066350
- P30CA016056 (U.S. NIH Grant/Contract)
- RUH-SSH-190-0600
- RUH-SSH-190-0698
- NCI-V98-1425
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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