Back to resultsA Study to See Whether a Nutritional Supplement is Beneficial for Patients With Pancreatic Cancer
Primary Purpose
Pancreatic Cancer
Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Nutritional Supplement
Placebo
Sponsored by
About this trial
This is an interventional basic science trial for Pancreatic Cancer
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Nutritional Supplement
Placebo
Arm Description
2 nutritional supplement capsules, taken by mouth 3 times per day, for approximately 10 to 15 weeks.
2 placebo capsules, taken by mouth 3 times per day, for approximately 10 to 15 weeks.
Outcomes
Primary Outcome Measures
Muscle fatty acid content
Quantification of muscle triglyceride fatty acid (ug/g)
Secondary Outcome Measures
Plasma levels of the nutritional supplement
Quantification of the plasma concentration of nutritional supplement components (ug/mL)
Determine computed tomography (CT)-derived body composition
Quantitatively determine body composition as assessed by computed tomography (CT) scans, relative to stature (cm2/m2)
Plasma C-reactive protein
Plasma quantification of C-reactive protein (mg/dL)
Full Information
NCT ID
NCT02745197
First Posted
January 13, 2016
Last Updated
October 12, 2018
Sponsor
University of Alberta
1. Study Identification
Unique Protocol Identification Number
NCT02745197
Brief Title
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
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Withdrawn
Why Stopped
change in concept
Study Start Date
May 2017 (Anticipated)
Primary Completion Date
October 2018 (Anticipated)
Study Completion Date
October 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Alberta
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Nutritional Supplement
Arm Type
Experimental
Arm Description
2 nutritional supplement capsules, taken by mouth 3 times per day, for approximately 10 to 15 weeks.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
2 placebo capsules, taken by mouth 3 times per day, for approximately 10 to 15 weeks.
Intervention Type
Dietary Supplement
Intervention Name(s)
Nutritional Supplement
Intervention Description
Participants will take 2 capsules, containing the nutritional supplement, 3 times per day.
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Participants will take 2 capsules, containing a placebo, 3 times per day.
Primary Outcome Measure Information:
Title
Muscle fatty acid content
Description
Quantification of muscle triglyceride fatty acid (ug/g)
Time Frame
At time of tumor removal surgery
Secondary Outcome Measure Information:
Title
Plasma levels of the nutritional supplement
Description
Quantification of the plasma concentration of nutritional supplement components (ug/mL)
Time Frame
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)
Title
Determine computed tomography (CT)-derived body composition
Description
Quantitatively determine body composition as assessed by computed tomography (CT) scans, relative to stature (cm2/m2)
Time Frame
Within 45 days before tumor removal surgery, and day of post-surgery follow-up CT scan (an average of 8-10 weeks after surgery)
Title
Plasma C-reactive protein
Description
Plasma quantification of C-reactive protein (mg/dL)
Time Frame
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)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vera Mazurak, Ph.D.
Organizational Affiliation
University of Alberta
Official's Role
Principal Investigator
12. IPD Sharing Statement
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A Study to See Whether a Nutritional Supplement is Beneficial for Patients With Pancreatic Cancer
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