Curcumin for the Chemoprevention of Colorectal Cancer

Adenomatous Polyps Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00118989
• Other study ID #: 802193
• Status: Terminated
• Phase: N/A
• First received: July 2, 2005
• Last updated: April 18, 2017
• Start date: July 2005
• Est. completion date: July 2012

Study information

• Verified date: April 2017
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 56
• Est. completion date: July 2012
• Est. primary completion date: September 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adenomatous Polyps
• Polyps

Intervention

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

Locations

Country	Name	City	State
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pennsylvania	Robert Wood Johnson Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cellular proliferation and apoptosis in the colonic mucosa		4 months
Secondary	COX-2 expression and activity		4 months