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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-07-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Colorectal Cancer

Study Design

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Primary Study Purpose

PREVENTION

Interventions

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curcumin

Intervention Type DIETARY_SUPPLEMENT

high performance liquid chromatography

Intervention Type OTHER

laboratory biomarker analysis

Intervention Type OTHER

pharmacological study

Intervention Type OTHER

diagnostic endoscopic procedure

Intervention Type PROCEDURE

therapeutic conventional surgery

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No