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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.

Verified September 2009 by National Cancer Institute (NCI).
Recruitment status was: Recruiting

Sponsor:

Information provided by:

National Cancer Institute (NCI)

ClinicalTrials.gov Identifier:

NCT00973869

First received: September 5, 2009

Last updated: June 23, 2014

Last verified: September 2009

History of Changes

Purpose

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	Intervention	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


Study Type:	Interventional
Study Design:	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

Resource links provided by NLM:

MedlinePlus related topics: Colorectal Cancer Endoscopy

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

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


Estimated Enrollment:	30
Study Start Date:	July 2009
Estimated Primary Completion Date:	January 2010 (Final data collection date for primary outcome measure)

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.

Eligibility


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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00973869

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


ClinicalTrials.gov Identifier:	NCT00973869 History of Changes
Other Study ID Numbers:	CDR0000648267 LRI-UL-CURCUMIN EUDRACT-2007-001971-13 EU-20961
Study First Received:	September 5, 2009
Last Updated:	June 23, 2014

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

ClinicalTrials.gov processed this record on July 21, 2017

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