Curcumin for the Chemoprevention of Colorectal Cancer

University of Pennsylvania

Status

Terminated

Conditions

Adenomatous Polyps

Treatments

Dietary Supplement: Curcuminoids

Study type

Interventional

Funder types

Other

Identifiers

NCT00118989

802193

Details and patient eligibility

About

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.

Enrollment

56 patients

Sex

All

Ages

18+ years old

Volunteers

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