Curcumin for the Chemoprevention of Colorectal Cancer

NCT ID: NCT00118989

Last Updated: 2017-04-20

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-07-31
• Study Completion Date: 2012-07-31

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.

Conditions

Adenomatous Polyps

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

PLACEBO

placebo to be taken orally via capsule form in the dose of 4 grams daily for a duration of four months

Group Type: PLACEBO_COMPARATOR

Curcuminoids

Intervention Type: DIETARY_SUPPLEMENT

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

Curcuminoids C3 Complex® to be taken orally via caps

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

Group Type: EXPERIMENTAL

Curcuminoids

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

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

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Curcuminoids C3 Complex® (Sabinsa Co.)

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Robert Wood Johnson Foundation

OTHER

Sponsor Role: collaborator

University of Pennsylvania

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Carmen E Guerra, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

802193

Identifier Type: -

Identifier Source: org_study_id