Curcumin for the Chemoprevention of Colorectal Cancer
Adenomatous Polyps
About this trial
This is an interventional prevention trial for Adenomatous Polyps focused on measuring Curcumin, chemoprevention, adenomatous polyps, colorectal cancer
Eligibility 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
Sites / Locations
- University of Pennsylvania
Arms of the Study
Arm 1
Arm 2
Placebo Comparator
Experimental
PLACEBO
Curcuminoids C3 Complex® to be taken orally via caps
placebo to be taken orally via capsule form in the dose of 4 grams daily for a duration of four months
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