Curcumin for the Chemoprevention of Colorectal Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2011 by University of Pennsylvania.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Robert Wood Johnson Foundation
Information provided by (Responsible Party):
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT00118989
First received: July 2, 2005
Last updated: November 14, 2011
Last verified: November 2011

July 2, 2005
November 14, 2011
July 2005
September 2010   (final data collection date for primary outcome measure)
Cellular proliferation and apoptosis in the colonic mucosa [ Time Frame: 4 months ] [ Designated as safety issue: No ]
Cellular proliferation and apoptosis in the colonic mucosa
Complete list of historical versions of study NCT00118989 on ClinicalTrials.gov Archive Site
COX-2 expression and activity [ Time Frame: 4 months ] [ Designated as safety issue: No ]
COX-2 expression and activity
Not Provided
Not Provided
 
Curcumin for the Chemoprevention of Colorectal Cancer
Phase II Double Blind Placebo-Controlled Trial of Curcuminoids' Effect on Cellular Proliferation, Apoptosis and COX-2 Expression in the Colorectal Mucosa of Subjects With Recently Resected Sporadic Adenomatous Polyps

Specific Aims:

  • To determine if curcuminoids modulate cellular proliferation as measured by proliferating cell nuclear antigen (PCNA) in the colorectal mucosa of subjects with previously resected adenomatous colonic polyps.

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Adenomatous Polyps
Drug: Curcuminoids
Curcuminoids C3 Complex® or placebo to be taken orally via capsule form in the dose of 4 grams daily for a duration of four months
Other Name: Curcuminoids C3 Complex® (Sabinsa Co.)
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
56
July 2012
September 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00118989
802193
No
University of Pennsylvania
University of Pennsylvania
Robert Wood Johnson Foundation
Principal Investigator: Carmen E Guerra, M.D. University of Pennsylvania
University of Pennsylvania
November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP