Status:
TERMINATED
Efficacy Study of Long-term Parenteral Nutrition With SmofKabiven® E in Lung Cancer Patients Under Anticancer Therapy
Lead Sponsor:
Fresenius Kabi
Conditions:
Cancer-related Malnutrition
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The purpose of this study is to determine the efficacy of long-term addition of SmofKabiven® E to normal oral nutrition after routine dietary counseling as compared to standard of care nutrition in wh...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
- Uncontrolled hyperglycaemia
- Unstable conditions (e.g., embolism, metabolic acidosis, hypotonic dehydration)
- Pregnancy or lactation
- 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
- Prior inclusion in the present study
Key Trial Info
Start Date :
February 28 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 5 2019
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT03355079
Start Date
February 28 2018
End Date
April 5 2019
Last Update
May 1 2019
Active Locations (1)
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1
Hôpital Cochin
Paris, France, 75014