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Curcumin for the Chemoprevention of Colorectal Cancer - Article


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Colon Polyps

Colonic Polyps; What I need to know about Colon Polyps


Clinical Trial: Curcumin for the Chemoprevention of Colorectal Cancer

This study is not yet open for patient recruitment.

Sponsors and Collaborators: University of Pennsylvania
Robert Wood Johnson Foundation
Information provided by: University of Pennsylvania

Purpose

Specific Aims:

Hypothesis: Curcuminoids decrease cellular proliferation in the colorectal mucosa of subjects with previously resected sporadic adenomatous colonic polyps.

  • To determine if curcuminoids modulate apoptosis, as measured by TUNEL assay, in the colorectal mucosa of subjects with previously resected adenomatous colonic polyps.

Hypothesis: Curcuminoids increase apoptosis in colorectal mucosa of subjects with previously resected sporadic adenomatous colonic polyps.

  • To determine if curcuminoids modulate COX-2 expression as measured by immunohistochemical assays in subjects with previously resected adenomatous colonic polyps

Hypothesis: Curcuminoids decrease colorectal mucosa COX-2 expression in subjects with previously resected sporadic adenomatous colonic polyps.

  • To determine if curcuminoids modulate COX-2 activity as measured by urinary eicosanoids

Hypothesis: Curcuminoids decrease concentrations of urinary eicosanoids.

Condition Intervention Phase
Adenomatous Polyps
 Drug: Curcuminoids
Phase II

MedlinePlus related topics:  Cancer;   Cancer Alternative Therapy

Study Type: Interventional
Study Design: Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Official Title: Phase II Double Blind Placebo-Controlled Trial of Curcuminoid''''s Effect On Cellular Proliferation, Apoptosis and COX-2 Expression in the Colorectal Mucosa of Subjects with Recently Resected Sporadic Adenomatous Polyps

Further Study Details: 
Primary Outcomes: Cellular proliferation and apoptosis in the colonic mucosa
Secondary Outcomes: COX-2 expression and activity
Expected Total Enrollment:  68

Study start: July 2005

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Accepts Healthy Volunteers

Criteria

Inclusion Criteria:

  • Age>18
  • A diagnosis for colon/rectal polyp resection, polypectomy
  • Subjects must be able to have the capacity and must be willing to provide informed consent
  • Premenopausal women must be surgically incapable of childbearing or be using a medically acceptable method of contraception (oral contraceptives, diaphragms, condoms with spermicide, IUD, progesterone injection or implant) throughout the entire length of the study
  • Men should wear condoms during the duration of the study given the unknown effects of curcumin on sperm viability, fertility

Exclusion Criteria:

  • Previous or current history of colorectal cancer
  • Previous history of Familial Polyposis Syndromes
  • Previous history of inflammatory bowel disease
  • Previous surgery of the large bowel
  • Liver disease defined as AST and ALT>3x upper limit of normal
  • Known history of gallstones, biliary colic or serum bilirubin >2.0
  • Cardiac disease including myocardial infarction, congestive heart failure, arrhythmia
  • Renal disease defined as creatinine >1.5
  • Hematopoietic disease defined as WBC<4000, platelet count <100,000, hemoglobin<10.0 or coagulation or bleeding disorder
  • Significantly impaired gastrointestinal function or absorption
  • Peptic ulcer disease
  • Active infection including viral, bacterial, atypical or fungal infections of any organ system including HIV
  • Previous history of allergy to turmeric, Indian curries, aspirin or NSAIDs
  • Pregnant or lactating women
  • Dementia or other neurologic or psychiatric disease which may impede the ability to follow the protocol
  • Inability to swallow pills
  • Prior or concurrent therapy with any herbal or dietary supplement containing curcuminoids
  • Concurrent use of anticoagulants or antiplatelets including warfarin, clopidogrel
  • Prior or concurrent use of colorectal cancer chemopreventive agents including herbals: Sulindac or other NSAIDs, aspirin, COX-2 inhibitors, 5-aminosalicylate, folate, calcium, or their use within 14 days of enrollment
  • Concurrent use of immunosuppressants

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00118989

James Garrow      (215) 573-2572    james.garrow@uphs.upenn.edu

Pennsylvania
      University of Pennsylvania, Philadelphia,  Pennsylvania,  19104,  United States
James Garrow  215-573-2572    james.garrow@uphs.upenn.edu 
Carmen E Guerra, M.D.,  Principal Investigator

Study chairs or principal investigators

Carmen E Guerra, M.D.,  Principal Investigator,  University of Pennsylvania   

More Information

Study ID Numbers:  RWJ
Record last reviewed:  June 2005
Last Updated:  July 25, 2005
Record first received:  July 11, 2005
ClinicalTrials.gov Identifier:  NCT00118989
Health Authority: United States: Institutional Review Board
ClinicalTrials.gov processed this record on 2005-07-26


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July 26, 2008



Page Updated: September 30, 2005
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