- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00927485
Use of Curcumin for Treatment of Intestinal Adenomas in Familial Adenomatous Polyposis (FAP)
Familial Adenomatous Polyposis (FAP) is an autosomal dominant disorder characterized by the formation of multiple adenomatous colorectal polyps usually in the teenage years. Virtually, all patients with FAP will develop colorectal cancer on average by the 5th decade of life if prophylactic surgery is not performed. Besides, these individuals must have lifelong cancer surveillance of the remaining colorectum or ileum.
Use of nonsteroidal anti-inflammatory drug (NSAID), such as sulindac, or celecoxib, which selectively inhibits prostaglandin synthesis primarily via the inhibition of cyclogenase-2 (COX-2) have been shown to reduce the incidence and induce regression of adenomas in the rectum of patients with FAP. However, use of NSAIDs and COX-2 inhibitors is associated with significant comorbidity including renal and gastric toxicity and increased risk of vascular events. Therefore, identification of a chemopreventive agent that would have similar efficacy but less toxicity would enhance our ability to treat these patients. Therefore the following specific aim has been proposed:To determine in a randomized, double-blinded, placebo-controlled study the tolerability and efficacy of curcumin to regress intestinal adenomas by measuring duodenal and colorectal/ileal polyp number, and polyp size in patients with FAP.
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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San Juan, Puerto Rico, 00936
- University of Puerto Rico Comprehensive Cancer Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 21-85 years with FAP (with an intact colon or who have had surgery)
Exclusion Criteria:
- Mentally incompetent
- Female patients of childbearing age not on effective birth control
- Patients with WBC < 3,500/ml, platelet count < 100,000/ml, BUN > 25mg%, creatinine > 1.5mg%
- Patients unable to stop NSAIDS or aspirin use for the duration of the study
- Malignancy other than nonmelanoma skin cancer
- Active bacterial infection
- Patients with GERD (Gastro esophageal reflux disease)
- Patients with a history of peptic (stomach or duodenal) ulcer disease
- Patients on Warfarin or anti-platelet drugs
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Curcumin
|
Patients will be randomized to curcumin (3 curcumin pills twice a day for 12 months).
Other Names:
Questions about current and past lifestyle, health background, and medications.
This will take about 20 minutes.
Three tubes of blood at visits 0, 4 and 12 months.
Flexible sigmoidoscopy at baseline and every 4 months for the length of the study (4 months, 8 months, 12 months and 16 months).
We will take 2-4 tissue samples of the colon lining by a pinch biopsy.
Other: Biopsies (Upper endoscopy) Upper endoscopy at baseline and at 12 months.
We will take 2-4 tissue samples of the small intestine lining by a pinch biopsy.
|
Placebo Comparator: Placebo
Placebo (sugar pills)
|
Patients will be randomized to curcumin (3 curcumin pills twice a day for 12 months).
Other Names:
Questions about current and past lifestyle, health background, and medications.
This will take about 20 minutes.
Three tubes of blood at visits 0, 4 and 12 months.
Flexible sigmoidoscopy at baseline and every 4 months for the length of the study (4 months, 8 months, 12 months and 16 months).
We will take 2-4 tissue samples of the colon lining by a pinch biopsy.
Other: Biopsies (Upper endoscopy) Upper endoscopy at baseline and at 12 months.
We will take 2-4 tissue samples of the small intestine lining by a pinch biopsy.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Polyps
Time Frame: 5 years
|
To determine in a randomized, double-blinded, placebo-controlled study the tolerability and efficacy of curcumin to regress intestinal adenomas by measuring duodenal and colorectal/ileal polyp number in patients with FAP.
|
5 years
|
Size of Polyps
Time Frame: 5 years
|
To determine in a randomized, double-blinded, placebo-controlled study the tolerability and efficacy of curcumin to regress intestinal adenomas by measuring duodenal and colorectal/ileal polyp size in patients with FAP.
|
5 years
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Marcia R. Cruz-Correa, MD. PhD, University of Puerto Rico Comprehensive Cancer Center
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Genetic Diseases, Inborn
- Pharyngeal Neoplasms
- Otorhinolaryngologic Neoplasms
- Head and Neck Neoplasms
- Nasopharyngeal Diseases
- Pharyngeal Diseases
- Stomatognathic Diseases
- Otorhinolaryngologic Diseases
- Colonic Diseases
- Intestinal Diseases
- Intestinal Neoplasms
- Rectal Diseases
- Neoplastic Syndromes, Hereditary
- Adenomatous Polyps
- Intestinal Polyposis
- Nasopharyngeal Neoplasms
- Colorectal Neoplasms
- Adenoma
- Adenomatous Polyposis Coli
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Antineoplastic Agents
- Curcumin
Other Study ID Numbers
- Protocol A2210108-UPR
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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