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

Pancreatic Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02745197
• Other study ID #: HREBA-CC-15-0218
• Status: Withdrawn
• Phase: Phase 2
• Start date: May 2017
• Est. completion date: October 2018

Study information

• Verified date: October 2018
• Source: University of Alberta
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 2018
• Est. primary completion date: October 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Dietary Supplement:
• Nutritional Supplement
Participants will take 2 capsules, containing the nutritional supplement, 3 times per day.
• Placebo
Participants will take 2 capsules, containing a placebo, 3 times per day.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Alberta

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Muscle fatty acid content	Quantification of muscle triglyceride fatty acid (ug/g)	At time of tumor removal surgery
Secondary	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)
Secondary	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)
Secondary	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)