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Curcumin for the Chemoprevention of Colorectal Cancer

Primary Purpose

Adenomatous Polyps

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Curcuminoids
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Adenomatous Polyps focused on measuring Curcumin, chemoprevention, adenomatous polyps, colorectal cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Pennsylvania

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

PLACEBO

Curcuminoids C3 Complex® to be taken orally via caps

Arm Description

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

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

Outcomes

Primary Outcome Measures

Cellular proliferation and apoptosis in the colonic mucosa

Secondary Outcome Measures

COX-2 expression and activity

Full Information

First Posted
July 2, 2005
Last Updated
April 18, 2017
Sponsor
University of Pennsylvania
Collaborators
Robert Wood Johnson Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT00118989
Brief Title
Curcumin for the Chemoprevention of Colorectal Cancer
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Terminated
Why Stopped
Could not be completed due to technology problems and cost constraints
Study Start Date
July 2005 (undefined)
Primary Completion Date
September 2010 (Actual)
Study Completion Date
July 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pennsylvania
Collaborators
Robert Wood Johnson Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adenomatous Polyps
Keywords
Curcumin, chemoprevention, adenomatous polyps, colorectal cancer

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
56 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PLACEBO
Arm Type
Placebo Comparator
Arm Description
placebo to be taken orally via capsule form in the dose of 4 grams daily for a duration of four months
Arm Title
Curcuminoids C3 Complex® to be taken orally via caps
Arm Type
Experimental
Arm Description
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
Intervention Name(s)
Curcuminoids
Other Intervention Name(s)
Curcuminoids C3 Complex® (Sabinsa Co.)
Intervention Description
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
Primary Outcome Measure Information:
Title
Cellular proliferation and apoptosis in the colonic mucosa
Time Frame
4 months
Secondary Outcome Measure Information:
Title
COX-2 expression and activity
Time Frame
4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carmen E Guerra, M.D.
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Curcumin for the Chemoprevention of Colorectal Cancer

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