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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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, Senior)
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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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
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