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
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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 |
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 Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 30 participants |
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 |
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

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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
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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

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
United Kingdom | |
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 wps1@le.ac.uk |
Principal Investigator: | William P. Steward, MD, PhD | University Hospitals, Leicester |
ClinicalTrials.gov Identifier: | NCT00973869 History of Changes |
Other Study ID Numbers: |
CDR0000648267 LRI-UL-CURCUMIN EUDRACT-2007-001971-13 EU-20961 |
First Posted: | September 9, 2009 Key Record Dates |
Last Update Posted: | June 24, 2014 |
Last Verified: | September 2009 |
Keywords provided by National Cancer Institute (NCI):
colon cancer rectal cancer |
Additional relevant MeSH terms:
Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases Curcumin |
Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents Antirheumatic Agents Antineoplastic Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |