Curcumin in Preventing Colorectal Cancer in Patients Undergoing Colorectal Endoscopy or Colorectal Surgery
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|ClinicalTrials.gov Identifier: NCT00973869|
Recruitment Status : Unknown
Verified September 2009 by National Cancer Institute (NCI).
Recruitment status was: Recruiting
First Posted : September 9, 2009
Last Update Posted : June 24, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Cancer||Dietary Supplement: curcumin Other: high performance liquid chromatography Other: laboratory biomarker analysis Other: pharmacological study Procedure: diagnostic endoscopic procedure Procedure: therapeutic conventional surgery||Phase 1|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|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 Start Date :||July 2009|
|Estimated Primary Completion Date :||January 2010|
- Concentration of curcumin in colorectal tissue after treatment
- Tolerability and compliance
- Presence of curcumin and its metabolites in peripheral blood and urine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00973869
|St. Mark's Hospital||Recruiting|
|Harrow, England, United Kingdom, HA1 3UJ|
|Contact: Contact Person 44-20-8235-4225|
|Leicester Royal Infirmary||Recruiting|
|Leicester, England, United Kingdom, LE1 5WW|
|Contact: William P. Steward, MD, PhD 44-116-258-7597 firstname.lastname@example.org|
|Principal Investigator:||William P. Steward, MD, PhD||University Hospitals, Leicester|