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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Curcumin | Experimental | Curcumin |
|
| Placebo | Placebo Comparator | Placebo (sugar pills) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Calcumin (Curcumin) | Drug | Patients will be randomized to curcumin (3 curcumin pills twice a day for 12 months). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Polyps | 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 | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marcia R. Cruz-Correa, MD. PhD | University of Puerto Rico Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Puerto Rico Comprehensive Cancer Center | San Juan | 00936 | Puerto Rico |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29802852 | Result | 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. |
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Absence of effective birth control; pregnancy; WBC < 3500/ml; platelet < 100,000/ml, BUN > 25 mg/dl, Creat > 1.5 mg/dl; malignancy; unwillingness to discontinue NSAIDs; active reflux; hx of peptic ulcer; active bacterial infection; use of warfarin or antiplatelets; allergy to curcumin. 3 month washout period for individuals taking NSAIDs, curcumin, turmeric, aspirin, calcium, vitamin D, green tea or polyphenol E
The study was conducted from September 2011 to November 2016 at the Johns Hopkins Hospital and the University of Puerto Rico Medical Sciences Campus. Participants were identified and recruited from the Johns Hopkins Polyposis Registry or from the University of Puerto Rico Familial Colorectal Cancer Registry.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Risk Factor Questionnaire | Other | Questions about current and past lifestyle, health background, and medications. This will take about 20 minutes. |
|
| Blood samples | Other | Three tubes of blood at visits 0, 4 and 12 months. |
|
| Biopsies (Sigmoidoscopy) | Other | 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 | 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. |
|
| FG001 | 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. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Polyps | 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. | Posted | Mean | 95% Confidence Interval | Number of Polyps | 5 years |
|
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| |||||||||||||||||||||||||||||
| Primary | Size of Polyps | 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. | Posted | Mean | 95% Confidence Interval | mm | 5 years |
|
Five Years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 0 | 21 | 5 | 21 | ||
| EG001 | 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. | 0 | 23 | 5 | 23 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal Pain | Gastrointestinal disorders | Systematic Assessment |
| ||
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Marcia Cruz-Correa | University of Puerto Rico Medical Sciences Campus | 787-758-2525 | 1722 | marcia.cruz1@upr.edu |
| ID | Term |
|---|---|
| D011125 | Adenomatous Polyposis Coli |
| ID | Term |
|---|---|
| D018256 | Adenomatous Polyps |
| D000236 | Adenoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009386 | Neoplastic Syndromes, Hereditary |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D044483 | Intestinal Polyposis |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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| ID | Term |
|---|---|
| D003474 | Curcumin |
| D001800 | Blood Specimen Collection |
| D001706 | Biopsy |
| D012812 | Sigmoidoscopy |
| D005773 | Gastroscopy |
| ID | Term |
|---|---|
| D036381 | Diarylheptanoids |
| D006536 | Heptanes |
| D000473 | Alkanes |
| D006839 | Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
| D003581 | Cytodiagnosis |
| D003584 | Cytological Techniques |
| D003949 | Diagnostic Techniques, Surgical |
| D003113 | Colonoscopy |
| D016099 | Endoscopy, Gastrointestinal |
| D016145 | Endoscopy, Digestive System |
| D003938 | Diagnostic Techniques, Digestive System |
| D004724 | Endoscopy |
| D013505 | Digestive System Surgical Procedures |
| D019060 | Minimally Invasive Surgical Procedures |
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| >=65 years |
|
| Male |
|
|
|