Spots Global Cancer Trial Database for Curcumin in Preventing Colorectal Cancer in Patients Undergoing Colorectal Endoscopy or Colorectal Surgery

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Trial Identification

Brief Title: Curcumin in Preventing Colorectal Cancer in Patients Undergoing Colorectal Endoscopy or Colorectal Surgery

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

Study ID: NCT00973869

Conditions

Colorectal Cancer

Interventions

curcumin

high performance liquid chromatography

laboratory biomarker analysis

pharmacological study

diagnostic endoscopic procedure

therapeutic conventional surgery

Study Description

Brief Summary: 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.

Detailed Description: 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.