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

University of Leicester

Status and phase: Unknown; Phase 1

Conditions: Colorectal Cancer

Treatments: Other: laboratory biomarker analysis; Procedure: diagnostic endoscopic procedure; Other: pharmacological study; Dietary Supplement: curcumin; Procedure: therapeutic conventional surgery; Other: high performance liquid chromatography

Study type: Interventional

Funder types: Other

Identifiers

NCT00973869

EUDRACT-2007-001971-13

CDR0000648267

LRI-UL-CURCUMIN

EU-20961

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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