Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Fresenius Kabi
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Metastatic non-small cell lung cancer patient
Adult ≥ 18 years
Starting any 1st, 2nd or 3rd line chemotherapy and/or immunotherapy administered via a central venous catheter (including implanted ports), or receiving the 2nd cycle of aforementioned anticancer treatment
An energy gap of ≥ 40 % and/or 1000 kcal between the target energy intake (30 ± 5 kcal/kg/day) and the actual energy intake at screening, irrespective of weight loss
Functional digestive tract allowing oral intake
If female of childbearing potential, willing to use a sufficiently safe contraception method throughout participation in the study
Signed informed consent from patient or legal representative
You may not be if
Parenteral nutrition (PN) administered during the preceding month (the sole administration of intravenous glucose is allowed), or standard of care PN planned to start within 3 weeks after baseline visit
More than 1600 kcal/day required as PN
Tube feeding at screening, or planned to start within 3 weeks after baseline visit
Body mass index (BMI) \> 30 kg/m2
Performance status \> 3 Eastern Cooperative Oncology Group (ECOG) score
Life expectancy \< 3 months
Active bloodstream infection demonstrated by positive blood culture at Screening
Hypersensitivity to fish-, egg, soya- or peanut protein or to any of the active substances or excipients in SmofKabiven E
Severe blood coagulation disorders
Congenital errors of amino acid metabolism
Pathologically elevated serum levels of any of the included electrolytes
General contraindications to infusion therapy: acute pulmonary oedema, hyperhydration, decompensated cardiac insufficiency
Hemophagocytotic Syndrome
Severe hyperlipidemia (serum triglycerides \> 353 mg/dL)
Severe liver insufficiency: liver enzymes (aspartate aminotransferase \[AST\], alanine aminotransferase \[ALT\], gamma glutamyl transferase \[GGT\]) or conjugated bilirubin exceeding 3 x upper limit of normal range, or International Normalised Ratio (INR) \> 2
Severe renal dysfunction (estimated glomerular filtration rate \[eGFR\] \< 30 ml/min/1.73m2) and patients on renal replacement therapy
Contraindications to any of the study assessment methods including computer tomography and indirect calorimetry
Participation in a clinical study with an investigational drug or investigational medical device within one month prior to start of study or during study
