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Curcumin for the Chemoprevention of Colorectal Cancer

This study has been terminated.
(Could not be completed due to technology problems and cost constraints)
Sponsor:
Collaborator:
Robert Wood Johnson Foundation
Information provided by (Responsible Party):
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT00118989
First received: July 2, 2005
Last updated: April 18, 2017
Last verified: April 2017
  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
Adenomatous Polyps Dietary Supplement: Curcuminoids

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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

Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • Cellular proliferation and apoptosis in the colonic mucosa [ Time Frame: 4 months ]

Secondary Outcome Measures:
  • COX-2 expression and activity [ Time Frame: 4 months ]

Enrollment: 56
Study Start Date: July 2005
Study Completion Date: July 2012
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: PLACEBO
placebo to be taken orally via capsule form in the dose of 4 grams daily for a duration of four months
Dietary Supplement: 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.)
Experimental: 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
Dietary Supplement: 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   (Adult, Senior)
Sexes Eligible for Study:   All
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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: April 18, 2017

Studies a U.S. FDA-regulated Drug Product: No

Keywords provided by University of Pennsylvania:
Curcumin
chemoprevention
adenomatous polyps
colorectal cancer

Additional relevant MeSH terms:
Polyps
Adenomatous Polyps
Pathological Conditions, Anatomical
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Curcumin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 21, 2017