Status:
TERMINATED
Curcumin for the Chemoprevention of Colorectal Cancer
Lead Sponsor:
University of Pennsylvania
Collaborating Sponsors:
Robert Wood Johnson Foundation
Conditions:
Adenomatous Polyps
Eligibility:
All Genders
18+ years
Phase:
NA
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 ad...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2012
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT00118989
Start Date
July 1 2005
End Date
July 1 2012
Last Update
April 20 2017
Active Locations (1)
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1
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104