Cachexia, NSCLC
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTNutrifriend Cachexia
2 daily for 12 weeks
DIETARY_SUPPLEMENTIsocaloric placebo
2 daily for 12 weeks
Sponsors
Smartfish AS
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* First-line standard chemotherapy as curative or palliative treatment for NSCLC * Will start the first cycle of standard chemotherapy * Eastern Cooperative Oncology Group (ECOG) performance status of ≤2 * Involuntary weight loss
Exclusion criteria
* Another invasive malignancy in the last 2 years. * Previous relapse of NSCLC within 2 years of randomisation * Other cachectic disorders such as renal or hepatic disorders
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and tolerability assessed by (adverse events, concomitant medication and laboratory markers) of Nutrifriend Cachexia in patients with NSCLC | 12 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Function assessed by walking distance | 12 weeks | — |
| Compliance assessed by Drinks consumed | 12 weeks | — |
| Compliance assessed by vitamin D levels | 12 weeks | — |
| Compliance assessed by Omega-3 incorporation | 12 weeks | — |
| Body composition assessed by fat mass and lean body mass (LBM) | 12 weeks | — |
| Body composition assessed by weight | 12 weeks | — |
| Body composition assessed by BMI | 12 weeks | — |
| Body composition assessed by waist circumference | 12 weeks | — |
| Body composition assessed by calf circumference | 12 weeks | — |
| Function assessed by 6 minute walking test | 12 weeks | — |
| Function assessed by grip strength | 12 weeks | — |
| Inflammation | 12 weeks | IL-6, IL-8, TNF-alpha, CRP |
| Metabolic markers | 12 weeks | Glucose, insulin, cholesterol, HbA1c |
| QoL assessed by EORTC QLQ-C3 | 12 weeks | — |
| QoL assessed by Functional Assessment of Anorexia/Cachexia Therapy (FAACT) questionnaire | 12 weeks | — |
| QoL assessed by Nutrition Appetite Questionnaire (CNAQ) | 12 weeks | — |
Other
| Measure | Time frame |
|---|---|
| Exploratory biomarkers related to cachexia, e.g. carnosine, beta-alanine | 12 weeks |
| Overall survival | 52 weeks |
| Response to chemotherapy by tumor growth | 12 weeks |
Countries
Croatia, Italy, Slovakia, Sweden
Outcome results
None listed