The Effect of Plant Phenolic Compounds on Human Colon Epithelial Cells
- 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
- 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
Allocation: Randomized, Primary Purpose: Prevention
Steven J. Shiff, MD
Cancer Institute of New Jersey
United States: Federal Government
|Rockefeller University Hospital||New York, New York 10021-6399|