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

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Pancreatic Cancer
• Intervention / Treatment: Dietary supplement: Nutritional Supplement; Dietary supplement: Placebo

• Study Type: Interventional
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Nutritional Supplement; 2 nutritional supplement capsules, taken by mouth 3 times per day, for approximately 10 to 15 weeks.	Dietary supplement: Nutritional Supplement; Participants will take 2 capsules, containing the nutritional supplement, 3 times per day.
PLACEBO_COMPARATOR: Placebo; 2 placebo capsules, taken by mouth 3 times per day, for approximately 10 to 15 weeks.	Dietary supplement: Placebo; Participants will take 2 capsules, containing a placebo, 3 times per day.

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: University of Alberta

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): May 1, 2017
• Primary Completion (ANTICIPATED): October 1, 2018
• Study Completion (ANTICIPATED): October 1, 2018

Study Registration Dates

• First Submitted: January 13, 2016
• First Submitted That Met QC Criteria: April 19, 2016
• First Posted (ESTIMATE): April 20, 2016

Study Record Updates

• Last Update Posted (ACTUAL): October 16, 2018
• Last Update Submitted That Met QC Criteria: October 12, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Endocrine System Diseases; Digestive System Neoplasms; Endocrine Gland Neoplasms; Pancreatic Diseases; Pancreatic Neoplasms
• Other Study ID Numbers: HREBA-CC-15-0218

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No