Pancreatic cancer/Biliary cancer
Conditions
Interventions
The intervention group received at least 2 packs (375 mL/600 kcal) of Inolas (pharmaceutical product) per day, and the following endpoints were tested before and every 4 weeks after administration (st
Sponsors
The Jikei University School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients with unresectable pancreatic or cbiliary cancer who are undergoing chemotherapy and have given consent for this clinical trial.
Exclusion criteria
Exclusion criteria: 1 PS 3,4 (according to ECOG criteria) 2 Difficulty in oral intake 3 Active infectious disease 4 History of hypersensitivity to administered drugs (or equivalent supplements) or milk protein (Inolas contains milk protein) 5 Poorly controlled diabetes mellitus (HbA1c 7.0percents or higher) 6 Duplication of cancer outside the biliary-pancreatic region 7 Receiving warfarin 8 Plt<100,000 9 Patients with severe hepatic or renal impairment 10 Inborn error of amino acid metabolism 11 In case the attending physician deems it inappropriate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| skeletal muscle mass | — |
Secondary
| Measure | Time frame |
|---|---|
| Weight, chemotherapy response rate, chemotherapy tolerability (adverse event rate, chemotherapy continuation rate), overall survival, blood sampling data (blood EPA concentration, EPA/AA ratio, Glasgow prognostic score (CRP, Alb), serum proteins (TP, retinol binding protein (RBP), prealbumin), white blood cells (neutrophils), IL-6, NK cell activity White blood cells (neutrophils), IL-6, NK cell activity, HbA1c (pancreatic cancer only), CEA, CA19-9), QOL score | — |
Countries
Japan
Contacts
Public ContactKyohei Abe
The Jikei University School of Medicine Department of Surgery
Outcome results
None listed