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

NCT02745197 | Withdrawn Phase 2

• 1 other identifier: HREBA-CC-15-0218
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

• Muscle fatty acid content

  Quantification of muscle triglyceride fatty acid (ug/g)

  At time of tumor removal surgery

Secondary Outcomes (3)

• 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)

• 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)

• 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)

Study Arms (2)

Nutritional Supplement

EXPERIMENTAL

2 nutritional supplement capsules, taken by mouth 3 times per day, for approximately 10 to 15 weeks.

Dietary Supplement: Nutritional Supplement

Placebo

PLACEBO COMPARATOR

2 placebo capsules, taken by mouth 3 times per day, for approximately 10 to 15 weeks.

Dietary Supplement: Placebo

Interventions

Nutritional Supplement DIETARY_SUPPLEMENT

Participants will take 2 capsules, containing the nutritional supplement, 3 times per day.

Nutritional Supplement

Placebo DIETARY_SUPPLEMENT

Participants will take 2 capsules, containing a placebo, 3 times per day.

Placebo

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Alberta: lead

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Dietary Supplements

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Vera Mazurak, Ph.D.

  University of Alberta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2016
• First Posted: April 20, 2016
• Study Start: May 1, 2017
• Primary Completion: October 1, 2018
• Study Completion: October 1, 2018
• Last Updated: September 19, 2024

Record last verified: 2018-10