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 which oral nutrition is the primary nutritional support. It takes place in lung cancer patients under chemo- and/or immunotherapy. Efficacy will be determined primarily by calculating the change of patient's body weight from before start of study treatment to end of treatment, and comparing this change between both treatment groups.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
2
In the intervention arm, SmofKabiven® E, with or without addition of Suppliven®, Vitalipid® Adult and/or Soluvit®, will be administered in addition to standard of care oral nutrition as per dietary counseling, whereas in the control arm, oral nutrition as per dietary counseling is the primary nutritional support.
Hôpital Cochin
Paris, France
Change in total body weight (kg)
Time frame: Every 2-3 weeks, for up to 9 +/-1 weeks
Serum albumin
Time frame: Every 2-3 weeks from baseline to final visit at 9 +/1 weeks after baseline
Serum transthyretin
Time frame: Every 2-3 weeks from baseline to final visit at 9 +/1 weeks after baseline
Nutritional Risk Index
Time frame: Every 2-3 weeks from baseline to final visit at 9 +/1 weeks after baseline
Unplanned PN or tube feeding according to standard of care in control group
Time frame: Every 2-3 weeks from baseline to final visit at 9 +/1 weeks after baseline
Early termination of PN due to improvement in test group
Time frame: Every 2-3 weeks from baseline to final visit at 9 +/1 weeks after baseline
Lean body mass determined from computer tomography (CT) scan at 3rd lumbar vertebra
Time frame: Baseline to final visit at 9 +/1 weeks after baseline
Optional: lean tissue mass, phase angle and hydration status including intra- and extracellular body water with bioelectrical impedance analysis (BIA), if BIA device is available.
Time frame: Baseline to final visit at 9 +/1 weeks after baseline
Karnofsky performance status
Time frame: Every 2-3 weeks from baseline to final visit at 9 +/1 weeks after baseline
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ECOG performance status
Time frame: Time Frame: Every 2-3 weeks from baseline to final visit at 9 +/1 weeks after baseline
Handgrip strength in kg, using hand dynamometer
Time frame: Every 2-3 weeks from baseline to final visit at 9 +/1 weeks after baseline
Actual and target number of completed chemotherapy and/or immunotherapy cycles
Time frame: Every 2-3 weeks from baseline to 3 months after baseline
Actual dose and target chemotherapy and/or immunotherapy dose administered
Time frame: Every 2-3 weeks from baseline to 3 months after baseline
Chemotherapy and/or immunotherapy toxicities according to NCI-CTC v4.0 including dose-limiting toxicities
Time frame: Every 2-3 weeks from baseline to final visit at 9 +/1 weeks after baseline
Fatigue using the brief fatigue inventory (BFI questionnaire)
Time frame: Every 2-3 weeks from baseline to final visit at 9 +/1 weeks after baseline
Overall survival
Time frame: Until 6 months post baseline
Progression-free survival
Time frame: At 3 and 6 months post baseline
Partial response rate (as per RECIST v 1.1)
Time frame: At 9 +/-1 weeks, 3 months and 6 months after baseline
Complete response rate (as per RECIST v 1.1)
Time frame: At 9 +/-1 weeks, 3 months and 6 months after baseline
Unplanned hospitalization
Time frame: From baseline until 6 months after baseline
Quality of life (Functional Assessment of Cancer Therapy- General [FACT-G] score)
Time frame: From baseline until final visit at 9 +/-1 weeks after baseline
Number of patients terminating anti-cancer and nutrition therapy as part of end-of-life care
Time frame: From baseline until final visit at 9 +/-1 weeks after baseline
Resting energy expenditure
measured by indirect calorimetry
Time frame: From baseline until final visit at 9 +/-1 weeks after baseline
Ocurrence of unplanned admission to nursing home
Time frame: From baseline until final visit at 9 +/-1 weeks after baseline