Nutrition Supplementation in Improving Outcomes in Patients with Pancreatic Cancer That Cannot Be Removed by Surgery

This randomized clinical trial studies how well nutrition supplementation works in improving outcomes in patients with pancreatic cancer that cannot be removed by surgery. Nutrition supplementation such as protein powder may improve energy intake, body weight, body composition, and quality of life in patients with pancreatic cancer.

Inclusion Criteria

• Unresectable pancreatic adenocarcinoma, receiving either 1) no chemotherapy 2) 1st cycle of chemotherapy or 3) greater than 1 cycle of chemotherapy if the patient’s prognosis is greater than 6 months as determined by oncology collaborators
• Weight loss of greater than 5% in the previous 6 months
• Life expectancy of greater than 3 months and a Karnofsky performance score of 60 or more
• Non-smokers

Exclusion Criteria

• Surgical treatment in the previous month
• Consumption of dietary supplements or medications such as steroids that could affect metabolism
• Ascites requiring paracentesis for symptom improvement
• Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) values greater than 5 times the upper limit of normal
• Creatinine value greater than 2.0 for men and 1.5 for women
• Severe anemia with hemoglobin (HGB) < 10
• Uncontrolled pain
• Uncontrolled nausea and vomiting
• Participation in a therapeutic research study within 30 days of baseline
• Diet restrictions including vegetarianism, veganism, soy-free diet
• Fish and/or fish oil allergy or intolerance
• Milk allergy excluding lactose intolerance
• Use of Warfarin

PRIMARY OBJECTIVES:

I. To examine the effect of dietary prescription with and without nutrition supplementation in patients with unresectable pancreatic cancer on: body weight, body composition and total calorie intake, quality of life, and blood inflammatory markers.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients undergo dietary counseling on days 1, 28, 56, 84 and 112. Patients also receive protein powder supplement three times a day (TID) during weeks 1-16.

ARM II: Patients undergo dietary counseling on days 1, 28, 56, 84 and 112.

Lead Organization
UCLA / Jonsson Comprehensive Cancer Center

Principal Investigator
ZhaoPing Li

Primary ID 15-001926
Secondary IDs NCI-2016-01225
Clinicaltrials.gov ID NCT02681601