Curcumin for the Chemoprevention of Colorectal Cancer

Stopped early · Not applicable · Has a placebo group

Conditions studied: Adenomatous Polyps

In brief

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.

Key facts

Study ID

NCT00118989

Run by

University of Pennsylvania

People needed

56

Starts

2005-07-01

Expected to finish

2012-07-01

Last updated by the study team

2017-04-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Pennsylvania — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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