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

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
• 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
• 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 OBJECTIVE:

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.

Trial Phase Phase NA

Trial Type Supportive care

Lead Organization
UCLA / Jonsson Comprehensive Cancer Center

Principal Investigator
ZhaoPing Li

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