Use of Curcumin for Treatment of Intestinal Adenomas in Familial Adenomatous Polyposis (FAP)
NCT ID: NCT00927485
Last Updated: 2020-12-16
Study Results
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View full resultsBasic Information
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COMPLETED
NA
44 participants
INTERVENTIONAL
2007-11-30
2016-12-31
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Curcumin
Curcumin
Calcumin (Curcumin)
Patients will be randomized to curcumin (3 curcumin pills twice a day for 12 months).
Risk Factor Questionnaire
Questions about current and past lifestyle, health background, and medications. This will take about 20 minutes.
Blood samples
Three tubes of blood at visits 0, 4 and 12 months.
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.
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
Placebo (sugar pills)
Calcumin (Curcumin)
Patients will be randomized to curcumin (3 curcumin pills twice a day for 12 months).
Risk Factor Questionnaire
Questions about current and past lifestyle, health background, and medications. This will take about 20 minutes.
Blood samples
Three tubes of blood at visits 0, 4 and 12 months.
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.
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.
Interventions
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Calcumin (Curcumin)
Patients will be randomized to curcumin (3 curcumin pills twice a day for 12 months).
Risk Factor Questionnaire
Questions about current and past lifestyle, health background, and medications. This will take about 20 minutes.
Blood samples
Three tubes of blood at visits 0, 4 and 12 months.
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.
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
21 Years
85 Years
ALL
No
Sponsors
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National Institutes of Health (NIH)
NIH
University of Puerto Rico
OTHER
Responsible Party
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Marcia R. Cruz-Correa, MD, PhD
Director of Gastrointestinal Oncology
Principal Investigators
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Marcia R. Cruz-Correa, MD. PhD
Role: PRINCIPAL_INVESTIGATOR
University of Puerto Rico Comprehensive Cancer Center
Locations
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University of Puerto Rico Comprehensive Cancer Center
San Juan, , Puerto Rico
Countries
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References
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Cruz-Correa M, Hylind LM, Marrero JH, Zahurak ML, Murray-Stewart T, Casero RA Jr, Montgomery EA, Iacobuzio-Donahue C, Brosens LA, Offerhaus GJ, Umar A, Rodriguez LM, Giardiello FM. Efficacy and Safety of Curcumin in Treatment of Intestinal Adenomas in Patients With Familial Adenomatous Polyposis. Gastroenterology. 2018 Sep;155(3):668-673. doi: 10.1053/j.gastro.2018.05.031. Epub 2018 May 23.
Other Identifiers
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Protocol A2210108-UPR
Identifier Type: -
Identifier Source: org_study_id