EUCTR2017-001559-30-FR进行中（未招募）1 期
Efficacy of long-term parenteral nutrition with SmofKabiven® E concomitant to chemo- and/or immunotherapy: A prospective, randomised, controlled, open, multicentre, two-stage, adaptive clinical trial in metastatic non-small cell lung cancer - SmofKabiven® E long-term Parenteral Nutrition in Oncology
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 162
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •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
排除标准
- •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
研究者
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