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

University of Alberta

Status and phase: Withdrawn; Phase 2

Conditions: Pancreatic Cancer

Treatments: Dietary Supplement: Nutritional Supplement; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02745197

HREBA-CC-15-0218

Details and patient eligibility

About

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.

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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0 participants in 2 patient groups, including a placebo group

Nutritional Supplement

Experimental group

Description:

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

Treatment:

Dietary Supplement: Nutritional Supplement

Placebo

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: Placebo