Curcumin in Preventing Colorectal Cancer in Patients Undergoing Colorectal Endoscopy or Colorectal Surgery
Recruitment status was: Recruiting
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.
Dietary Supplement: curcumin
Other: high performance liquid chromatography
Other: laboratory biomarker analysis
Other: pharmacological study
Procedure: diagnostic endoscopic procedure
Procedure: therapeutic conventional surgery
|Study Design:||Primary Purpose: Prevention|
|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|
- Concentration of curcumin in colorectal tissue after treatment [ Designated as safety issue: No ]
- Tolerability and compliance [ Designated as safety issue: No ]
- Presence of curcumin and its metabolites in peripheral blood and urine [ Designated as safety issue: No ]
|Study Start Date:||July 2009|
|Estimated Primary Completion Date:||January 2010 (Final data collection date for primary outcome measure)|
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00973869
|St. Mark's Hospital|
|Harrow, England, United Kingdom, HA1 3UJ|
|Leicester Royal Infirmary|
|Leicester, England, United Kingdom, LE1 5WW|
|Principal Investigator:||William P. Steward, MD, PhD||University Hospitals, Leicester|