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

Study Overview
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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.

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.

Official Title
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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

Conditions
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Colorectal Cancer

Intervention / Treatment
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* Dietary Supplement: curcumin
* Other: high performance liquid chromatography
* Other: laboratory biomarker analysis
* Other: pharmacological study
* Procedure: diagnostic endoscopic procedure
* Procedure: therapeutic conventional surgery


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention


Arms and Interventions

| Intervention/Treatment |
| --- |
|Dietary Supplement: curcumin|nan|
|Other: high performance liquid chromatography|nan|
|Other: laboratory biomarker analysis|nan|
|Other: pharmacological study|nan|
|Procedure: diagnostic endoscopic procedure|nan|
|Procedure: therapeutic conventional surgery|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Concentration of curcumin in colorectal tissue after treatment |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tolerability and compliance |  |  | 
| Presence of curcumin and its metabolites in peripheral blood and urine |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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colon cancer, rectal cancer