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

Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IBiomarker/Laboratory analysis, PreventionActive18 and overOtherCDR0000648267
LRI-UL-CURCUMIN, EUDRACT-2007-001971-13, EU-20961, UL-CURCUMIN, NCT00973869

Trial Description

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.

Further Study Information

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 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

Trial Contact Information

Trial Lead Organizations/Sponsors

University Hospitals of Leicester NHS Trust

William P. StewardPrincipal Investigator

Trial Sites

United Kingdom
England
  Harrow
 St. Mark's Hospital
 Contact Person Ph: 44-20-8235-4225
  Leicester
 Leicester Royal Infirmary
 William P. Steward, MD, PhD Ph: 44-116-258-7597
  Email: wps1@le.ac.uk

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00973869
Information obtained from ClinicalTrials.gov on April 04, 2013

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.

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