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

University of Leicester30 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Purpose

PREVENTION

Enrollment

Conditions

Colorectal Cancer

Interventions

curcuminDIETARY_SUPPLEMENT

high performance liquid chromatographyOTHER

laboratory biomarker analysisOTHER

pharmacological studyOTHER

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (2)

St. Mark's Hospital

Harrow, England, United Kingdom

RECRUITING

Leicester Royal Infirmary

Leicester, England, United Kingdom

RECRUITING

Outcomes

Primary Outcomes

Concentration of curcumin in colorectal tissue after treatment

Secondary Outcomes

Tolerability and compliance

Presence of curcumin and its metabolites in peripheral blood and urine

Data from ClinicalTrials.gov

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