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change in concept
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This study evaluates a nutritional supplement in the treatment of pancreatic cancer in adults. Half of the participants will receive the nutritional supplement, while the other half will receive a placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nutritional Supplement | Experimental | 2 nutritional supplement capsules, taken by mouth 3 times per day, for approximately 10 to 15 weeks. |
|
| Placebo | Placebo Comparator | 2 placebo capsules, taken by mouth 3 times per day, for approximately 10 to 15 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nutritional Supplement | Dietary Supplement | Participants will take 2 capsules, containing the nutritional supplement, 3 times per day. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Muscle fatty acid content | Quantification of muscle triglyceride fatty acid (ug/g) | At time of tumor removal surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma levels of the nutritional supplement | Quantification of the plasma concentration of nutritional supplement components (ug/mL) | Baseline (before initiation of capsule consumption), day of tumor removal surgery (an average of 2-5 weeks from baseline), and day of post-surgery follow-up CT scan (an average of 8-10 weeks after surgery) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Vera Mazurak, Ph.D. | University of Alberta | Principal Investigator |
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| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
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| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| ID | Term |
|---|---|
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
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| Placebo | Dietary Supplement | Participants will take 2 capsules, containing a placebo, 3 times per day. |
|
| Determine computed tomography (CT)-derived body composition |
Quantitatively determine body composition as assessed by computed tomography (CT) scans, relative to stature (cm2/m2) |
| Within 45 days before tumor removal surgery, and day of post-surgery follow-up CT scan (an average of 8-10 weeks after surgery) |
| Plasma C-reactive protein | Plasma quantification of C-reactive protein (mg/dL) | Baseline (before initiation of capsule consumption), day of tumor removal surgery (an average of 2-5 weeks from baseline), and day of post-surgery follow-up CT scan (an average of 8-10 weeks after surgery) |
| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |