A Phase 1 interventional study of Curcumin C3 tablet in Colorectal Cancer, sponsored by University of North Carolina, Chapel Hill. Completed at 1 site in United States. Open to participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2013-02-07.
Sponsored by University of North Carolina, Chapel Hill · Phase 1 and Interventional
Colorectal cancer is a major problem in the United States and other developed countries. A safe and effective chemopreventive agent could reduce the burden of colorectal neoplasia. Curcumin, is a product that is derived from Curcuma longa. It has been used for thousands of years as a traditional remedy. Curcumin blocks a number of targets involved in tumor initiation, promotion, and progression, and is considered a promising chemopreventive agent. The investigators propose to enroll 40 patients after screening colonoscopy who will have rectal biopsies at baseline and after 4 weeks of curcumin 4 grams per day. The investigators will use microarray analysis to identify genes that are modified by curcumin that could be used as biomarkers in future chemoprevention studies. The study will also evaluate tolerability and toxicity.
5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,459 are open to participants now.
This study's enrollment of 40 is below the median of 77 across 4,123 interventional studies indexed under Colorectal Neoplasms.
Browse Colorectal Neoplasms studies →University of North Carolina, Chapel Hill is the lead sponsor of 1,340 studies on the registry; 133 are open to participants now.
Of its 155 completed or terminated interventional studies of FDA-regulated products, 136 (88%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
4g Curcumin C3 tablet daily
Drug: Curcumin C3 tablet
4 grams Curcumin C3 tablet daily x30 days
Gene expression
Change in gene expression
Time frame: 30 days
Ribonucleic acid (RNA) level
Transcript level as mRNA copies per cell
Time frame: 30 days
Apoptosis
Immunohistochemistry (IHC) signal as intensity and proportion of cells stained
Time frame: 30 days
Number of Participants with Adverse Events
Time frame: 30 days
This study is completed, as verified in Jan 2013. You cannot join it, but the record below documents what was studied.
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University of North Carolina, Chapel Hill