A Study To See Whether A Nutritional Supplement Is Beneficial For Patients With Pancreatic Cancer

Study Overview

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

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.

N/A

Pancreatic Cancer

DIETARY_SUPPLEMENT: Nutritional Supplement
DIETARY_SUPPLEMENT: Placebo

HREBA-CC-15-0218

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2016-01-13	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2024-09-11
First Submitted that Met QC Criteria 2016-04-19	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2024-09-19
First Posted (ACTUAL) 2016-04-20	Results First Posted N/A	Last Verified 2018-10

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Basic Science

Allocation:
Randomized

Interventional Model:
Parallel

Masking:
Quadruple

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.

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.

Primary Outcome Measures	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	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)

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
19 Years

Accepts Healthy Volunteers:

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.

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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

PRINCIPAL_INVESTIGATOR: Vera Mazurak, Ph.D., University of Alberta

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Resources

PatientS

Caregivers

Clinical Trial Record