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

Primary Purpose

Colorectal Cancer

Status
Unknown status
Phase
Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
curcumin
high performance liquid chromatography
laboratory biomarker analysis
pharmacological study
diagnostic endoscopic procedure
therapeutic conventional surgery
Sponsored by
University of Leicester
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Colorectal Cancer focused on measuring colon cancer, rectal cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • St. Mark's HospitalRecruiting
  • Leicester Royal InfirmaryRecruiting

Outcomes

Primary Outcome Measures

Concentration of curcumin in colorectal tissue after treatment

Secondary Outcome Measures

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

Full Information

First Posted
September 5, 2009
Last Updated
June 23, 2014
Sponsor
University of Leicester
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1. Study Identification

Unique Protocol Identification Number
NCT00973869
Brief Title
Curcumin in Preventing Colorectal Cancer in Patients Undergoing Colorectal Endoscopy or Colorectal Surgery
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 Type
Interventional

2. Study Status

Record Verification Date
September 2009
Overall Recruitment Status
Unknown status
Study Start Date
July 2009 (undefined)
Primary Completion Date
January 2010 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
University of Leicester

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
colon cancer, rectal cancer

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Dietary Supplement
Intervention Name(s)
curcumin
Intervention Type
Other
Intervention Name(s)
high performance liquid chromatography
Intervention Type
Other
Intervention Name(s)
laboratory biomarker analysis
Intervention Type
Other
Intervention Name(s)
pharmacological study
Intervention Type
Procedure
Intervention Name(s)
diagnostic endoscopic procedure
Intervention Type
Procedure
Intervention Name(s)
therapeutic conventional surgery
Primary Outcome Measure Information:
Title
Concentration of curcumin in colorectal tissue after treatment
Secondary Outcome Measure Information:
Title
Tolerability and compliance
Title
Presence of curcumin and its metabolites in peripheral blood and urine

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William P. Steward, MD, PhD
Organizational Affiliation
University Hospitals, Leicester
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Mark's Hospital
City
Harrow
State/Province
England
ZIP/Postal Code
HA1 3UJ
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Contact Person
Phone
44-20-8235-4225
Facility Name
Leicester Royal Infirmary
City
Leicester
State/Province
England
ZIP/Postal Code
LE1 5WW
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
William P. Steward, MD, PhD
Phone
44-116-258-7597
Email
wps1@le.ac.uk

12. IPD Sharing Statement

Learn more about this trial

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

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