Nutrition Supplementation in Improving Outcomes in Patients with Pancreatic Cancer That Cannot Be Removed by Surgery
- 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
- 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
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
UCLA / Jonsson Comprehensive Cancer Center
- Primary ID 15-001926
- Secondary IDs NCI-2016-01225
- Clinicaltrials.gov ID NCT02681601