Sulindac and Plant Compounds in Preventing Colon Cancer
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|ClinicalTrials.gov Identifier: NCT00003365|
Recruitment Status : Terminated (Study completed)
First Posted : May 21, 2004
Last Update Posted : January 27, 2011
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.
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Cancer||Dietary Supplement: curcumin Dietary Supplement: rutin Drug: quercetin Drug: sulindac||Not Applicable|
- 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 :||Interventional (Clinical Trial)|
|Official Title:||The Effect of Plant Phenolic Compounds on Human Colon Epithelial Cells|
|Study Start Date :||August 1996|
|Actual Primary Completion Date :||July 2006|
|Actual Study Completion Date :||July 2006|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003365
|United States, New York|
|Rockefeller University Hospital|
|New York, New York, United States, 10021-6399|
|Study Chair:||Steven J. Shiff, MD||Rutgers Cancer Institute of New Jersey|