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

Phase 2

Withdrawn

• Conditions: Pancreatic Cancer
• Interventions: Dietary Supplement: Nutritional Supplement; Dietary Supplement: Placebo

• Registration Number: NCT02745197
• Lead Sponsor: University of Alberta

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study First Submitted: 2016-01-13
• Study First Submitted QC: 2016-04-19
• Study First Posted: 2016-04-20
• Study Start: 2017-05
• Status Verified: 2018-10
• Primary Completion: 2018-10
• Study Completion: 2018-10
• Last Update Submitted: 2018-10-12
• Last Update Posted: 2018-10-16

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nutritional Supplement	Nutritional Supplement	2 nutritional supplement capsules, taken by mouth 3 times per day, for approximately 10 to 15 weeks.
Placebo	Placebo	2 placebo capsules, taken by mouth 3 times per day, for approximately 10 to 15 weeks.

Primary Outcome Measures

Name	Time	Method
Muscle fatty acid content	At time of tumor removal surgery	Quantification of muscle triglyceride fatty acid (ug/g)

Secondary Outcome Measures

Name	Time	Method
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)
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)