Effects of SmofKabiven® E, a nutrition solution given into the vein, in lung cancer patients

Phase 1

• Conditions: Metastatic Non-Small Cell Lung Cancer; MedDRA version: 20.0 Level: PT Classification code 10059515 Term: Non-small cell lung cancer metastatic System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2017-001559-30-FR
• Lead Sponsor: Fresenius Kabi Deutschland GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-08-31
• Last Update Posted: 30 April 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 162

Inclusion Criteria

1. Metastatic NSCLC patient
2. Adult = 18 years
3. Starting any 1st, 2nd or 3rd line chemotherapy and/or immunotherapy administered via a central venous catheter (including implanted ports)
4. Moderate malnutrition defined by = 5 % weight loss in the last month or = 10% in the last 6 months
5. An energy gap of = 40 % between the target energy intake (30 ± 5 kcal/kg/day) and the actual energy intake at screening
6. Functional digestive tract allowing oral intake
7. Signed informed consent from patient or legal representative

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 81
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 81

Exclusion Criteria

1. PN administered during the preceding month (the sole administration of intravenous glucose is allowed)
2. More than 1600 kcal/day required as PN
3. Tube feeding at screening
4. Severe malnutrition defined by = 10 % weight loss in the last month or = 15 % weight loss in the last 6 months
5. Body mass index (BMI) > 30 kg/m2
6. Performance status > 3 Eastern Cooperative Oncology Group (ECOG) score
7. Life expectancy < 3 months
8. Active bloodstream infection demonstrated by positive blood culture at screening
9. Hypersensitivity to fish-, egg, soya- or peanut protein or to any of the active substances or excipients in SmofKabiven E
10. Severe blood coagulation disorders
11. Congenital errors of amino acid metabolism
12. Pathologically elevated serum levels of any of the included electrolytes
13. General contraindications to infusion therapy: acute pulmonary oedema, hyperhydration, decompensated cardiac insufficiency
14. Hemophagocytotic syndrome
15. Severe hyperlipidemia (serum triglycerides > 353 mg/dL)
16. 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
17. Severe renal dysfunction (estimated glomerular filtration rate [eGFR] < 30 ml/min/1.73m2) and patients on renal replacement therapy
18. Uncontrolled hyperglycaemia
19. Unstable conditions (e.g., embolism, metabolic acidosis, hypotonic dehydration)
20. Pregnancy or lactation
21. Contraindications to any of the study assessment methods including computer tomography and indirect calorimetry
22. Participation in a clinical study with an investigational drug or investigational medical device within one month prior to start of study or during study
23. Prior inclusion in the present study

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified