A comparative study on the long-term results of nutritional support using enteral nutrition for patients undergoing chemotherapy for unresectable pancreatic and biliary tract cancer
Not Applicable
Recruiting
- Conditions
- Pancreatic cancer/Biliary cancer
- Registration Number
- JPRN-UMIN000043223
- Lead Sponsor
- The Jikei University School of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 66
Inclusion Criteria
Not provided
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method skeletal muscle mass
- Secondary Outcome Measures
Name Time Method 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