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

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

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.

Study Overview

• Status: Unknown
• Conditions: Colorectal Cancer
• Intervention / Treatment: Other: pharmacological study; Other: laboratory biomarker analysis; Procedure: therapeutic conventional surgery; Other: high performance liquid chromatography; Dietary supplement: curcumin; Procedure: diagnostic endoscopic procedure

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 Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Phase 1

Contacts and Locations

Study Locations

• United Kingdom
  • England
    • Harrow, England, United Kingdom, HA1 3UJ
      • Recruiting
      • St. Mark's Hospital
      • Contact: Contact Person; Phone Number: 44-20-8235-4225
    • Leicester, England, United Kingdom, LE1 5WW
      • Recruiting
      • Leicester Royal Infirmary
      • Contact: William P. Steward, MD, PhD; Phone Number: 44-116-258-7597; Email: wps1@le.ac.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Concentration of curcumin in colorectal tissue after treatment

Secondary Outcome Measures

Outcome Measure
Tolerability and compliance
Presence of curcumin and its metabolites in peripheral blood and urine

Collaborators and Investigators

• Sponsor: University of Leicester
• Investigators: Principal Investigator: William P. Steward, MD, PhD, University Hospitals, Leicester

Study record dates

Study Major Dates

• Study Start: July 1, 2009
• Primary Completion (Anticipated): January 1, 2010

Study Registration Dates

• First Submitted: September 5, 2009
• First Submitted That Met QC Criteria: September 5, 2009
• First Posted (Estimate): September 9, 2009

Study Record Updates

• Last Update Posted (Estimate): June 24, 2014
• Last Update Submitted That Met QC Criteria: June 23, 2014
• Last Verified: September 1, 2009

More Information

Terms related to this study

• Keywords: rectal cancer; colon cancer
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Antineoplastic Agents; Curcumin
• Other Study ID Numbers: CDR0000648267; LRI-UL-CURCUMIN; EUDRACT-2007-001971-13; EU-20961