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.
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Purpose
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 | 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
Secondary Outcomes: COX-2 expression and activity
Expected Total Enrollment: 68
Study start: July 2005
Eligibility
Accepts Healthy Volunteers
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
Pennsylvania
University of Pennsylvania, Philadelphia, Pennsylvania, 19104, United States
Carmen E Guerra, M.D., Principal Investigator
Carmen E Guerra, M.D., Principal Investigator, University of Pennsylvania
More Information
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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