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
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