Curcumin for the Chemoprevention of Colorectal Cancer

• Status: Completed
• Trial end date: 0000-00-00
• Target enrollment: 56
• Participant gender: Both

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Pennsylvania
• Collaborator: Robert Wood Johnson Foundation
• Treatments: Curcumin
• Last Updated: 2014-12-12

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