Clinical trial NCT02745197: A Study to See Whether a Nutritional Supplement is Beneficial for Patients With Pancreatic Cancer
Official title: Factors That Regulate Components of a Nutritional Supplement to Support Skeletal Muscle in Cancer Patients
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Pancreatic Cancer
Lead sponsor: University of Alberta
Sponsor class: OTHER
First posted: 2016-04-20
Enrollment: 0
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Muscle fatty acid content
timeFrame: At time of tumor removal surgery
Secondary outcomes:
measure: Plasma levels of the nutritional supplement
timeFrame: 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)
measure: Determine computed tomography (CT)-derived body composition
timeFrame: Within 45 days before tumor removal surgery, and day of post-surgery follow-up CT scan (an average of 8-10 weeks after surgery)
measure: Plasma C-reactive protein
timeFrame: 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)
Other outcomes:
Locations:
Study officials:
affiliation: University of Alberta
name: Vera Mazurak, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: