Curcumin for the Chemoprevention of Colorectal Cancer
This study is ongoing, but not recruiting participants.
Sponsor:
University of Pennsylvania
Collaborator:
Robert Wood Johnson Foundation
Information provided by (Responsible Party):
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT00118989
First received: July 2, 2005
Last updated: November 14, 2011
Last verified: November 2011
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Adenomatous Polyps |
Drug: Curcuminoids |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Prevention |
| 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 |
Resource links provided by NLM:
Further study details as provided by University of Pennsylvania:
Primary Outcome Measures:
- Cellular proliferation and apoptosis in the colonic mucosa [ Time Frame: 4 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- COX-2 expression and activity [ Time Frame: 4 months ] [ Designated as safety issue: No ]
| Enrollment: | 56 |
| Study Start Date: | July 2005 |
| Estimated Study Completion Date: | July 2012 |
| Primary Completion Date: | September 2010 (Final data collection date for primary outcome measure) |
Intervention Details:
-
Drug: 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
Other Name: Curcuminoids C3 Complex® (Sabinsa Co.)
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00118989
Locations
| United States, Pennsylvania | |
| University of Pennsylvania | |
| Philadelphia, Pennsylvania, United States, 19104 | |
Sponsors and Collaborators
University of Pennsylvania
Robert Wood Johnson Foundation
Investigators
| Principal Investigator: | Carmen E Guerra, M.D. | University of Pennsylvania |
More Information
No publications provided
| Responsible Party: | University of Pennsylvania |
| ClinicalTrials.gov Identifier: | NCT00118989 History of Changes |
| Other Study ID Numbers: | 802193 |
| Study First Received: | July 2, 2005 |
| Last Updated: | November 14, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Pennsylvania:
|
Curcumin chemoprevention adenomatous polyps colorectal cancer |
Additional relevant MeSH terms:
|
Colorectal Neoplasms Polyps Adenomatous Polyps Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases Pathological Conditions, Anatomical Adenoma |
Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Curcumin Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Anti-Inflammatory Agents Therapeutic Uses Antirheumatic Agents Antineoplastic Agents Enzyme Inhibitors |
ClinicalTrials.gov processed this record on May 21, 2013