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PURPOSE: This phase II trial is studying how well curcumin works in preventing colon cancer in smokers with aberrant crypt foci.
- Determine mean percentage change in prostaglandin E_2 (PGE_2) within aberrant crypt foci (ACF) from baseline to 30 days after treatment with curcumin in current smokers.
- Determine the mean percentage change in 5-hydroxy-eicosatetraenoic acid (5-HETE) within ACF from baseline to 30 days after treatment with curcumin in these patients.
- Determine the mean percentage change in PGE_2 and 5-HETE within normal mucosa from baseline to 30 days after treatment with curcumin in these patients.
- Quantify corresponding enzyme changes in the cyclooxygenases (COX-1 and COX-2) and lipoxygenase (5-LOX) protein abundance in patients treated with curcumin.
- Document changes in total ACF number.
- Determine proliferation by Ki-67 immunohistochemistry (IHC) in rectal mucosa before and after treatment with curcumin and correlate changes in ACF number and size in these patients.
- Determine curcumin concentration in rectal mucosa after 30 days of treatment with curcumin and correlate with PGE_2 and 5-HETE changes described above in these patients.
- Measure glutathione peroxidase (GPx) activity within the colon before and after treatment with curcumin as an indirect marker of reduced oxidative stress within the colonic epithelium in these patients.
- Ensure the safety of all patients during course of study investigation.
OUTLINE: This is a multicenter, nonrandomized, uncontrolled study.
Patients receive 1 of 2 doses of oral curcumin once daily. Treatment continues for 30 days in the absence of unacceptable toxicity or disease progression.
Blood and tissue biopsies are obtained by sigmoidoscopy or colonoscopy at baseline and at day 30 for correlative biomarker studies. The change in prostaglandin E_2 (PGE_2) is assessed by enzyme immunoassay, 5-hydroxy-eicosatetraenoic acid (5-HETE) by high-performance liquid chromatography, cyclooxygenases (COX-1 and COX-2) and 5-lipoxygenase (5-LOX) by western blotting, Ki-67 by immunohistochemistry, and glutathione peroxidase (GPx) by spectrophotometric assay.
After completion of study therapy, patients are followed at 1 week.
PROJECTED ACCRUAL: A total of 48 patients will be accrued for this study.
Allocation: Non-Randomized, Control: Uncontrolled, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
University of Illinois Cancer Center
Active, not recruiting
University of California, Irvine
Published on BioPortfolio: 2014-08-27T03:43:01-0400
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