Curcumin for the Chemoprevention of Colorectal Cancer

Study Overview
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Brief Summary
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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.

Official Title
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Phase II Double Blind Placebo-Controlled Trial of Curcuminoids' Effect on Cellular Proliferation, Apoptosis and COX-2 Expression in the Colorectal Mucosa of Subjects With Recently Resected Sporadic Adenomatous Polyps

Conditions
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Adenomatous Polyps

Intervention / Treatment
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* Dietary Supplement: Curcuminoids


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: PLACEBO<br>placebo to be taken orally via capsule form in the dose of 4 grams daily for a duration of four months | Dietary Supplement: Curcuminoids<br>* 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<br>* Other names: Curcuminoids C3 Complex® (Sabinsa Co.);|
| Experimental: Curcuminoids C3 Complex® to be taken orally via caps<br>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 | Dietary Supplement: Curcuminoids<br>* 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<br>* Other names: Curcuminoids C3 Complex® (Sabinsa Co.);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cellular proliferation and apoptosis in the colonic mucosa |  | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| COX-2 expression and activity |  | 4 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Curcumin, chemoprevention, adenomatous polyps, colorectal cancer