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Curcumin for the Chemoprevention of Colorectal Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00118989
Recruitment Status : Terminated (Could not be completed due to technology problems and cost constraints)
First Posted : July 12, 2005
Last Update Posted : April 20, 2017
Sponsor:
Collaborator:
Robert Wood Johnson Foundation
Information provided by (Responsible Party):
University of Pennsylvania

Study Description
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Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Adenomatous Polyps Dietary Supplement: Curcuminoids Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: 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
Study Start Date : July 2005
Actual Primary Completion Date : September 2010
Actual Study Completion Date : July 2012
Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: PLACEBO
placebo to be taken orally via capsule form in the dose of 4 grams daily for a duration of four months
 Dietary Supplement: 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.)
Experimental: Curcuminoids C3 Complex® to be taken orally via caps
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
 Dietary Supplement: 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.)


Outcome Measures
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Primary Outcome Measures :
  1. Cellular proliferation and apoptosis in the colonic mucosa [ Time Frame: 4 months ]

Secondary Outcome Measures :
  1. COX-2 expression and activity [ Time Frame: 4 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00118989


Locations
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United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
Robert Wood Johnson Foundation
Investigators
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Principal Investigator: Carmen E Guerra, M.D. University of Pennsylvania
More Information
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Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT00118989    
Other Study ID Numbers: 802193
First Posted: July 12, 2005    Key Record Dates
Last Update Posted: April 20, 2017
Last Verified: April 2017

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Studies a U.S. FDA-regulated Drug Product: No
Keywords provided by University of Pennsylvania:
Curcumin
chemoprevention
adenomatous polyps
colorectal cancer
Additional relevant MeSH terms:
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Adenomatous Polyps
Polyps
Pathological Conditions, Anatomical
Adenoma
 Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms