A Study to See Whether a Nutritional Supplement is Beneficial for Patients With Pancreatic Cancer

Study Overview
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Brief Summary
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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.

Official Title
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Factors That Regulate Components of a Nutritional Supplement to Support Skeletal Muscle in Cancer Patients

Conditions
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Pancreatic Cancer

Intervention / Treatment
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* Dietary Supplement: Nutritional Supplement
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with a newly diagnosed pancreatic tumor thought to be pancreatic cancer scheduled for resection of the tumor. Patients with a newly diagnosed pancreatic tumor thought to be pancreatic cancer, subsequently found to have biliary or ampullary cancer upon full pathological review, scheduled for resection of the tumor. Patients with a CT image, which includes scans of the 3rd lumbar region, taken within 45 days before tumor resection surgery. Ability to maintain oral intake. Ability to give written, informed consent. Exclusion Criteria: Patients found to have a diagnosis other than pancreatic, biliary, or ampullary cancer upon full pathological review. Patients with a benign tumor. Patients taking drugs that modify muscle metabolism. Patients with uncontrolled jaundice. A compliance rate of <80%, excluding compliance during recovery from tumor resection surgery while in the hospital. Patients currently taking the nutritional supplement being investigated in this study. Patients in the placebo group who have plasma levels of the nutritional supplement components within the range of the nutritional supplement group at study time points when plasma levels of the nutritional supplement components are significantly higher in the nutritional supplement group versus the placebo group. Inadequate specimens. Known allergy to gelatin or glycerin.

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nutritional Supplement<br>2 nutritional supplement capsules, taken by mouth 3 times per day, for approximately 10 to 15 weeks. | Dietary Supplement: Nutritional Supplement<br>* Participants will take 2 capsules, containing the nutritional supplement, 3 times per day.<br>|
| Placebo Comparator: Placebo<br>2 placebo capsules, taken by mouth 3 times per day, for approximately 10 to 15 weeks. | Dietary Supplement: Placebo<br>* Participants will take 2 capsules, containing a placebo, 3 times per day.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Muscle fatty acid content | Quantification of muscle triglyceride fatty acid (ug/g) | At time of tumor removal surgery | 

Secondary Outcome Measures

| Outcome Measure | 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) | 
| 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) |