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This is a pilot study aimed at assessing the effects of moderate dose omega-3-acid ethyl esters capsules (generic Lovaza) on molecular, and intestinal microbiota changes in participants at high risk for colorectal cancer. The study will be a single arm, open label study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Omega-3, 2 grams | Experimental | Omega-3 fatty acid ethyl esters (2 grams) orally (by mouth) once per day for 12 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Omega-3 fatty acid ethyl esters (2 gram) | Drug | Omega-3 fatty acid ethyl esters (2 gram) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Retention rate of participants | Feasibility is defined as at least 80% retention rate | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants with treatment-related adverse events in each arm. | Measured by Common Terminology Criteria Adverse Events (CTCAE) V5.0 | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anwaar Saeed, MD | The University of Kansas Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Kansas Cancer Center, Westwood Campus | Kansas City | Kansas | 66205 | United States |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D003123 | Colorectal Neoplasms, Hereditary Nonpolyposis |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| C405603 | Omacor |
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| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D009386 | Neoplastic Syndromes, Hereditary |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D049914 | DNA Repair-Deficiency Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |