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
18 Years
N/A
Both
Colorectal Cancer
Trial Information
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
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.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Meets 1 of the following criteria:
- Has a positive fecal occult blood test found during a pilot colorectal cancer
screening program
- Awaiting diagnostic or surveillance colonoscopy
- Diagnosis of colorectal cancer
PATIENT CHARACTERISTICS:
- Able to return for follow-up tests
- Fertile patients must use effective contraception
- No discrete gastric or duodenal ulcer > 5 mm in the past year
- Patients with a history of Helicobacter pylori-related peptic ulcer disease are
eligible after successfully completing antibiotic treatment for Helicobacter
pylori
- No significant medical or psychiatric problem, including significant renal, hepatic,
or hematological dysfunction, that would make the patient a poor candidate for this
study
PRIOR CONCURRENT THERAPY:
- More than 3 months since prior investigational agents
- No prior pelvic radiotherapy
- No other concurrent investigational agents
Type of Study:
Interventional
Study Design:
Primary Purpose: Prevention
Outcome Measure:
Concentration of curcumin in colorectal tissue after treatment
Safety Issue:
No
Principal Investigator
William P. Steward, MD, PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
University Hospitals, Leicester
Authority:
Unspecified
Study ID:
CDR0000648267
NCT ID:
NCT00973869
Start Date:
July 2009
Completion Date:
Related Keywords:
- Colorectal Cancer
- colon cancer
- rectal cancer
- Colorectal Neoplasms
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