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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2009 by National Cancer Institute (NCI).
Recruitment status was:  Recruiting
Information provided by:
National Cancer Institute (NCI) Identifier:
First received: September 5, 2009
Last updated: June 23, 2014
Last verified: September 2009

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 Intervention 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

Study Type: Interventional
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

Resource links provided by NLM:

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Concentration of curcumin in colorectal tissue after treatment

Secondary Outcome Measures:
  • Tolerability and compliance
  • Presence of curcumin and its metabolites in peripheral blood and urine

Estimated Enrollment: 30
Study Start Date: July 2009
Estimated Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Detailed Description:



  • 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.


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


  • 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


  • 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


  • More than 3 months since prior investigational agents
  • No prior pelvic radiotherapy
  • No other concurrent investigational agents
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: 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   
Sponsors and Collaborators
University of Leicester
Principal Investigator: William P. Steward, MD, PhD University Hospitals, Leicester
  More Information Identifier: NCT00973869     History of Changes
Other Study ID Numbers: CDR0000648267
Study First Received: September 5, 2009
Last Updated: June 23, 2014

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
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
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 processed this record on September 21, 2017