Colorectal Cancer Clinical Trial
Official title:
A Pilot Study of Administration of Curcumin to Determine Colonic Curcumin Tissue Levels in Patients Awaiting Colorectal Endoscopy or Patients With Colorectal Cancer Awaiting Resection
RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming. The use
of curcumin may prevent or treat colorectal cancer.
PURPOSE: This phase I trial is studying the side effects of curcumin in preventing
colorectal cancer in patients undergoing colorectal endoscopy or colorectal surgery.
OBJECTIVES:
Primary
- To determine levels of curcumin and its metabolites in normal colorectal tissue in
patients undergoing colorectal endoscopy or colorectal cancer surgery following a
14-day course of curcumin.
Secondary
- To assess the practicality, acceptability, and safety of administering 5 capsules of
curcumin daily for 14 days.
- To check the presence of curcumin and its metabolites in peripheral blood and urine.
OUTLINE: Patients receive oral curcumin once daily for 14-28 days. Patients then undergo
colorectal endoscopy or resection.
Normal colorectal tissue samples are collected via biopsy for curcumin assay after the last
dose of curcumin. Patients also undergo blood and urine sample collection at baseline and
after the last dose of curcumin for pharmacokinetic analysis by high performance liquid
chromatography.
After completion of study treatment, patients are followed up at 14 days.
;
Primary Purpose: Prevention
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