Resectable and borderline resectable pancreatic cancer pateints
Conditions
Interventions
Patients assigned to the Nutrition intervention group received 2 bottles (440 ml) per day (560 kcal/day) of EPA-enriched nutritional supplement (Prosure
Abbott Japan, Tokyo, Japan) during the irradiation component of treatment (about 5 weeks).
Patients assigned to the Normal diet group have usual meal without special nutritional agent
Sponsors
Osaka International Cancer Institute
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients are enrolled in the study when they diagnose with untreated, histopathologically-confirmed, resectable pancreatic cancer (clinical stage IIA or IIB, according to TNM classification, 7th edition and scheduled to receive neoadjuvant chemoradiotherapy (NACRT)
Exclusion criteria
Exclusion criteria: Patients were excluded from the study when they don't met the following eligibility criteria: (1) an Eastern Cooperative Oncology Group performance status of 0-1; (2) adequate hepatic, renal, and bone-marrow reserves (AST and ALT levels below twice the normal levels; total serum bilirubin <3.0 mg/dl; creatinine level <1.3 mg/dl; leukocyte count>2,000/mm3; hemoglobin >10 g/dl; platelet count >100,000/mm3); (3) capable of oral intake, and (4) written informed consent provided before randomization.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The before-to-after NACRT ratios (post/pre ratios) of skeletal muscle mass and psoas major muscle area (PMA) | — |
Secondary
| Measure | Time frame |
|---|---|
| The post/pre ratios of other nutritional parameters and treatment-related toxicities | — |
Countries
Japan
Contacts
Public ContactHidenori Takahashi
Osaka International Cancer Institute Department of Surgery
Outcome results
None listed