Multicentre, randomised, open-label, parallel-group, clinical phase II study to evaluate immunonutrition in improving efficacy of immunotherapy in patients with metastatic non-small cell lung cancer, undergoing systematic nutritional counseling

Table 1 Assessments and related endpoints that will be investigated during the study

EVALUATIONS	T0 2 weeks before starting therapy	T1 Visit 1 Start of therapy	T2 Visit 2 Month 3	T3 Visit 3 Month 6	T4 Visit 4 Month 12 End of study
Informed consent	X
Demographic data	X
Inclusion/exclusion criteria	X
Randomisation	X
Weight history	X
Antropometric evaluation	X	X	X	X	X
Proteic-caloric needs evaluation	X	X	X	X	X
24 hours recall	X	X	X	X	X
ESAS Scale	X	X	X	X	X
Godin’s Shepard Leisure Time Questionnaire	X		X	X
EORTC QLQ-C30, EORTC QLQ-LC13 & FACT-L	X		X	X	X
FACIT-F	X				X
BIVA	X		X	X	X
Body composition	X		X	X	X
Immunological profile evaluation	X	X	X	X	X
Treatment efficacy			X	X	X
Adverse events		X	X	X	X
Compliance to oral nutritional supplements	X	X	X	X	X

ISSN: 1471-2407