Pancreatic Cancer
Conditions
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTNutritional Supplement
Participants will take 2 capsules, containing the nutritional supplement, 3 times per day.
DIETARY_SUPPLEMENTPlacebo
Participants will take 2 capsules, containing a placebo, 3 times per day.
Sponsors
University of Alberta
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Muscle fatty acid content | At time of tumor removal surgery | Quantification of muscle triglyceride fatty acid (ug/g) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Plasma levels of the nutritional supplement | 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) | Quantification of the plasma concentration of nutritional supplement components (ug/mL) |
| Determine computed tomography (CT)-derived body composition | Within 45 days before tumor removal surgery, and day of post-surgery follow-up CT scan (an average of 8-10 weeks after surgery) | Quantitatively determine body composition as assessed by computed tomography (CT) scans, relative to stature (cm2/m2) |
| Plasma C-reactive protein | 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) | Plasma quantification of C-reactive protein (mg/dL) |
Outcome results
None listed