Overview

This trial is active, not recruiting.

Condition adenomatous polyps
Treatment curcuminoids
Phase phase 2
Sponsor University of Pennsylvania
Collaborator Robert Wood Johnson Foundation
Start date July 2005
End date September 2010
Trial size 56 participants
Trial identifier NCT00118989, 802193

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose prevention

Primary Outcomes

Measure
Cellular proliferation and apoptosis in the colonic mucosa
time frame: 4 months

Secondary Outcomes

Measure
COX-2 expression and activity
time frame: 4 months

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title 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
Principal investigator Carmen E Guerra, M.D.
Trial information was received from ClinicalTrials.gov and was last updated in November 2011.
Information provided to ClinicalTrials.gov by University of Pennsylvania.