Curcumin in Preventing Colorectal Cancer in Patients Undergoing Colorectal Endoscopy or Colorectal Surgery

Phase 1

• Conditions: Colorectal Cancer

• Registration Number: NCT00973869
• Lead Sponsor: University of Leicester

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.

Study Timeline

• Study Start: 2009-07
• Status Verified: 2009-09
• Study First Submitted: 2009-09-05
• Study First Submitted QC: 2009-09-05
• Study First Posted: 2009-09-09
• Primary Completion: 2010-01
• Last Update Submitted: 2014-06-23
• Last Update Posted: 2014-06-24

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Concentration of curcumin in colorectal tissue after treatment

Secondary Outcome Measures

Name	Time	Method
Tolerability and compliance
Presence of curcumin and its metabolites in peripheral blood and urine

Trial Locations

Locations (2)

Leicester Royal Infirmary; 🇬🇧 Leicester, England, United Kingdom

St. Mark's Hospital; 🇬🇧 Harrow, England, United Kingdom