SF-C002 is a pilot study in patients with newly diagnosed NSCLC suffering from involuntary weight loss. The study is 12 weeks, double-blinded, placebo controlled and the main objective is to study the safety and tolerability of Nutrifriend Cachexia.
This study is a 12-week, randomised, parallel group, placebo controlled, multi-centre study. The primary objective is to evaluate the safety and tolerability of Nutrifriend Cachexia in patients with NSCLC. The secondary objectives of the study are to evaluate effects on body composition, muscle function, daily activity, inflammation, tumor growth, compliance, appetite and Quality of Life.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
56
2 daily for 12 weeks
2 daily for 12 weeks
GH Varaždin
Varaždin, Croatia
GH Zadar
Zadar, Croatia
CHC Sestre Milosrdnice
Zagreb, Croatia
Safety and tolerability assessed by (adverse events, concomitant medication and laboratory markers) of Nutrifriend Cachexia in patients with NSCLC
Time frame: 12 weeks
Body composition assessed by fat mass and lean body mass (LBM)
Time frame: 12 weeks
Body composition assessed by weight
Time frame: 12 weeks
Body composition assessed by BMI
Time frame: 12 weeks
Body composition assessed by waist circumference
Time frame: 12 weeks
Body composition assessed by calf circumference
Time frame: 12 weeks
Function assessed by 6 minute walking test
Time frame: 12 weeks
Function assessed by grip strength
Time frame: 12 weeks
Function assessed by walking distance
Time frame: 12 weeks
Inflammation
IL-6, IL-8, TNF-alpha, CRP
Time frame: 12 weeks
Metabolic markers
Glucose, insulin, cholesterol, HbA1c
Time frame: 12 weeks
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CHC Zagreb,
Zagreb, Croatia
Policlinico Universitario Campus Bio-Medico di Roma
Rome, Italy
Policlinico Tor Vergata
Rome, Italy
Azienda Ospedaliera San Camillo Forlanini
Rome, Italy
FNsP F.D. Roosvelta Banská Bystrica
Banská Bystrica, Slovakia
Nemocnica Sv. Jakuba
Bardejov, Slovakia
Východoslovenský onkologický ústav
Košice, Slovakia
...and 4 more locations
QoL assessed by EORTC QLQ-C3
Time frame: 12 weeks
QoL assessed by Functional Assessment of Anorexia/Cachexia Therapy (FAACT) questionnaire
Time frame: 12 weeks
QoL assessed by Nutrition Appetite Questionnaire (CNAQ)
Time frame: 12 weeks
Compliance assessed by Drinks consumed
Time frame: 12 weeks
Compliance assessed by vitamin D levels
Time frame: 12 weeks
Compliance assessed by Omega-3 incorporation
Time frame: 12 weeks