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

Colorectal Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00973869
• Other study ID #: CDR0000648267
• Secondary ID: LRI-UL-CURCUMINE
• Status: Recruiting
• Phase: Phase 1
• First received: September 5, 2009
• Last updated: June 23, 2014
• Start date: July 2009

Study information

• Verified date: September 2009
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Unspecified
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Primary Purpose: Prevention

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Dietary Supplement:
• curcumin

Other:
• high performance liquid chromatography

• laboratory biomarker analysis

• pharmacological study

Procedure:
• diagnostic endoscopic procedure

• therapeutic conventional surgery

Locations

Country	Name	City	State
United Kingdom	St. Mark's Hospital	Harrow	England
United Kingdom	Leicester Royal Infirmary	Leicester	England

Sponsors (1)

Lead Sponsor	Collaborator
University of Leicester

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Concentration of curcumin in colorectal tissue after treatment			No
Secondary	Tolerability and compliance			No
Secondary	Presence of curcumin and its metabolites in peripheral blood and urine			No