Use of Curcumin for Treatment of Intestinal Adenomas in Familial Adenomatous Polyposis (FAP)
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Familial Adenomatous Polyposis |
Drug: Calcumin (Curcumin) Other: Risk Factor Questionnaire Other: Blood samples Other: Biopsies (Sigmoidoscopy) Other: Biopsies (Upper endoscopy) |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | Use of Curcumin for Treatment of Intestinal Adenomas in Familial Adenomatous Polyposis (FAP) |
- 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. [ Time Frame: 5 years ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 50 |
| Study Start Date: | November 2007 |
| Estimated Study Completion Date: | November 2016 |
| Estimated Primary Completion Date: | November 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Curcumin
Curcumin
|
Drug: Calcumin (Curcumin)
Patients will be randomized to curcumin (3 curcumin pills twice a day for 12 months).
Other Name: Curcumin
Other: Risk Factor Questionnaire
Questions about current and past lifestyle, health background, and medications. This will take about 20 minutes.
Other: Blood samples
Three tubes of blood at visits 0, 4 and 12 months.
Other: Biopsies (Sigmoidoscopy)
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)
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)
|
Drug: Calcumin (Curcumin)
Patients will be randomized to curcumin (3 curcumin pills twice a day for 12 months).
Other Name: Curcumin
Other: Risk Factor Questionnaire
Questions about current and past lifestyle, health background, and medications. This will take about 20 minutes.
Other: Blood samples
Three tubes of blood at visits 0, 4 and 12 months.
Other: Biopsies (Sigmoidoscopy)
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)
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.
|
Detailed Description:
Patients will be randomized to curcumin (2 curcumin pills twice a day for 12 months) or placebo (2 pills twice a day for 12 months). Besides, blood samples, risk factor questionnaire,and biopsies (upper endoscopy and sigmoidoscopy) will be obtained.
Eligibility| Ages Eligible for Study: | 21 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Contact: Marcia R. Cruz-Correa, MD, PhD | 787-772-8300 ext 1214 | marcia.cruz1@upr.edu |
| Contact: Jessica Hernandez, MS | 787-360-8917 | jessica.hernandez8@upr.edu |
| Puerto Rico | |
| University of Puerto Rico Comprehensive Cancer Center | Recruiting |
| San Juan, Puerto Rico, 00936 | |
| Contact: Marcia R. Cruz-Correa, MD, PhD 787-772-8300 ext 1214 marcia.cruz1@upr.edu | |
| Contact: Jessica Hernandez, MS 787-360-8917 jessica.hernandez8@upr.edu | |
| Principal Investigator: Marcia R. Cruz-Correa, MD, PhD | |
| Sub-Investigator: Priscilla Magno, MD | |
| Principal Investigator: | Marcia R. Cruz-Correa, MD. PhD | University of Puerto Rico |
More Information
No publications provided
| Responsible Party: | Marcia R. Cruz-Correa, MD, PhD, University of Puerto Rico Comprehensive Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00927485 History of Changes |
| Other Study ID Numbers: | Protocol A2210108-UPR |
| Study First Received: | June 24, 2009 |
| Last Updated: | August 3, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by University of Puerto Rico:
|
Familial Adenomatous Polyposis (FAP) Curcumin Colorectal polyps Duodenal polyps |
Additional relevant MeSH terms:
|
Adenoma Adenomatous Polyposis Coli Colorectal Neoplasms Nasopharyngeal Neoplasms Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Adenomatous Polyps Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Colonic Neoplasms Neoplastic Syndromes, Hereditary Digestive System Diseases |
Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Intestinal Polyposis Genetic Diseases, Inborn Rectal Diseases Pharyngeal Neoplasms Otorhinolaryngologic Neoplasms Head and Neck Neoplasms Nasopharyngeal Diseases Pharyngeal Diseases Stomatognathic Diseases Otorhinolaryngologic Diseases Curcumin Anti-Inflammatory Agents, Non-Steroidal |
ClinicalTrials.gov processed this record on May 19, 2013