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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2009 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00973869
First received: September 5, 2009
Last updated: June 23, 2014
Last verified: September 2009
  Purpose

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 [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Tolerability and compliance [ Designated as safety issue: No ]
  • Presence of curcumin and its metabolites in peripheral blood and urine [ Designated as safety issue: No ]

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  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 ClinicalTrials.gov identifier: NCT00973869

Locations
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   
Sponsors and Collaborators
University of Leicester
Investigators
Principal Investigator: William P. Steward, MD, PhD University Hospitals, Leicester
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00973869     History of Changes
Other Study ID Numbers: CDR0000648267, LRI-UL-CURCUMIN, EUDRACT-2007-001971-13, EU-20961
Study First Received: September 5, 2009
Last Updated: June 23, 2014
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
colon cancer
rectal cancer

Additional relevant MeSH terms:
Colorectal Neoplasms
Colonic Diseases
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Intestinal Neoplasms
Neoplasms
Neoplasms by Site
Rectal Diseases
Curcumin
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antineoplastic Agents
Antirheumatic Agents
Central Nervous System Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 22, 2014