Adenomatous Polyps
Conditions
Keywords
Curcumin, chemoprevention, adenomatous polyps, colorectal cancer
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.
Interventions
DIETARY_SUPPLEMENTCurcuminoids
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
Sponsors
Robert Wood Johnson Foundation
University of Pennsylvania
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cellular proliferation and apoptosis in the colonic mucosa | 4 months |
Secondary
| Measure | Time frame |
|---|---|
| COX-2 expression and activity | 4 months |
Countries
United States
Outcome results
None listed