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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Information provided by:
National Cancer Institute (NCI)

Study Description
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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.


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

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 Design
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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy
Drug Information available for: Curcumin

Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Concentration of curcumin in colorectal tissue after treatment

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

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

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


Locations
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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
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Principal Investigator: William P. Steward, MD, PhD University Hospitals, Leicester
More Information
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ClinicalTrials.gov Identifier: NCT00973869    
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:
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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