Curcumin in Preventing Colorectal Cancer in Patients Undergoing Colorectal Endoscopy or Colorectal Surgery
The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2009 by National Cancer Institute (NCI).
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
University Hospitals, Leicester
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00973869
First received: September 5, 2009
Last updated: October 7, 2009
Last verified: September 2009
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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:
Further study details as provided by National Cancer Institute (NCI):
Primary Outcome Measures:
- Concentration of curcumin in colorectal tissue after treatment [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Tolerability and compliance [ Designated as safety issue: No ]
- Presence of curcumin and its metabolites in peripheral blood and urine [ Designated as safety issue: No ]
| Estimated Enrollment: | 30 |
| Study Start Date: | July 2009 |
| Estimated Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
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 |
| Genders Eligible for Study: | Both |
| 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
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 Hospitals, Leicester
Investigators
| Principal Investigator: | William P. Steward, MD, PhD | University Hospitals, Leicester |
More Information
Additional Information:
No publications provided
| 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: | October 7, 2009 |
| Health Authority: | Unspecified |
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 Pharmacologic Actions Anti-Inflammatory Agents Therapeutic Uses Antirheumatic Agents Antineoplastic Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Central Nervous System Agents |
ClinicalTrials.gov processed this record on June 17, 2013