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

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

Status

UNKNOWN

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00973869

Enrollment

Registered

2009-09-09

Start date

2009-07-31

Completion date

Unknown

Last updated

2014-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Cancer

Keywords

colon cancer, rectal cancer

Brief 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.

Detailed 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.

Interventions

DIETARY_SUPPLEMENTcurcumin

OTHERhigh performance liquid chromatography

OTHERlaboratory biomarker analysis

OTHERpharmacological study

PROCEDUREdiagnostic endoscopic procedure

PROCEDUREtherapeutic conventional surgery

Study design

Primary purpose

PREVENTION

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion 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

Design outcomes

Primary

Measure	Time frame
Concentration of curcumin in colorectal tissue after treatment	—

Secondary

Measure	Time frame
Tolerability and compliance	—
Presence of curcumin and its metabolites in peripheral blood and urine	—

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026