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

NCT00973869 | Unknown Phase 1

• 4 other identifiers: CDR0000648267LRI-UL-CURCUMINEUDRACT-2007-001971-13EU-20961
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

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.

Conditions

Colorectal Cancer

Keywords

colon cancer; rectal cancer

Outcome Measures

Primary Outcomes (1)

• Concentration of curcumin in colorectal tissue after treatment

Secondary Outcomes (2)

• Tolerability and compliance

• Presence of curcumin and its metabolites in peripheral blood and urine

Interventions

curcumin DIETARY_SUPPLEMENT

high performance liquid chromatography OTHER

laboratory biomarker analysis OTHER

pharmacological study OTHER

diagnostic endoscopic procedure PROCEDURE

therapeutic conventional surgery PROCEDURE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of Leicester: lead

Study Sites (2)

St. Mark's Hospital

Harrow, England, HA1 3UJ, United Kingdom

RECRUITING

Leicester Royal Infirmary

Leicester, England, LE1 5WW, United Kingdom

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms; Colonic Neoplasms; Rectal Neoplasms

Interventions

Curcumin; Chromatography, High Pressure Liquid

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Diarylheptanoids; Heptanes; Alkanes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Chromatography, Liquid; Chromatography; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• William P. Steward, MD, PhD

  University Hospitals, Leicester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Purpose: PREVENTION
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 5, 2009
• First Posted: September 9, 2009
• Study Start: July 1, 2009
• Primary Completion: January 1, 2010
• Last Updated: June 24, 2014

Record last verified: 2009-09

Locations

GB (2)