Clinical Trial: Curcumin for the Chemoprevention of Colorectal Cancer
Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional
Official Title: Phase II Double Blind Placebo-Controlled Trial of Curcuminoids' Effect on Cellular Proliferation, Apoptosis and COX-2 Expression in the Colorectal Mucosa of Subjects With Recently Resected Sporadic
Brief Summary:
Specific Aims:
- To determine if curcuminoids modulate cellular proliferation as measured by proliferating cell nuclear antigen (PCNA) in the colorectal mucosa of subjects with previously resected adenomatous colonic polyps.
Hypothesis: Curcuminoids decrease cellular proliferation in the colorectal mucosa of subjects with previously resected sporadic adenomatous colonic polyps.
- To determine if curcuminoids modulate apoptosis, as measured by TUNEL assay, in the colorectal mucosa of subjects with previously resected adenomatous colonic polyps.
Hypothesis: Curcuminoids increase apoptosis in colorectal mucosa of subjects with previously resected sporadic adenomatous colonic polyps.
- To determine if curcuminoids modulate COX-2 expression as measured by immunohistochemical assays in subjects with previously resected adenomatous colonic polyps
Hypothesis: Curcuminoids decrease colorectal mucosa COX-2 expression in subjects with previously resected sporadic adenomatous colonic polyps.
- To determine if curcuminoids modulate COX-2 activity as measured by urinary eicosanoids
Hypothesis: Curcuminoids decrease concentrations of urinary eicosanoids.
Detailed Summary:
Sponsor: University of Pennsylvania
Current Primary Outcome: Cellular proliferation and apoptosis in the colonic mucosa [ Time Frame: 4 months ]
Original Primary Outcome: Cellular proliferation and apoptosis in the colonic mucosa
Current Secondary Outcome: COX-2 expression and activity [ Time Frame: 4 months ]
Original Secondary Outcome: COX-2 expression and activity
Information By: University of Pennsylvania
Dates:
Date Received: July 2, 2005
Date Started: July 2005
Date Completion:
Last Updated: April 18, 2017
Last Verified: April 2017