Curcumin for the Chemoprevention of Colorectal Cancer

Not Applicable

Terminated

• Conditions: Adenomatous Polyps
• Interventions: Dietary Supplement: Curcuminoids

• Registration Number: NCT00118989
• Lead Sponsor: University of Pennsylvania

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-07
• Study First Submitted: 2005-07-02
• Study First Submitted QC: 2005-07-02
• Study First Posted: 2005-07-12
• Primary Completion: 2010-09
• Study Completion: 2012-07
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-18
• Last Update Posted: 2017-04-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 56

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PLACEBO	Curcuminoids	placebo to be taken orally via capsule form in the dose of 4 grams daily for a duration of four months
Curcuminoids C3 Complex® to be taken orally via caps	Curcuminoids	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

Primary Outcome Measures

Name	Time	Method
Cellular proliferation and apoptosis in the colonic mucosa	4 months

Secondary Outcome Measures

Name	Time	Method
COX-2 expression and activity	4 months

Trial Locations

Locations (1)

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States