Finding studies
Finding studies
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Lead
University of Medicine and Dentistry of New Jersey
With
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.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
