Pilot Study of Safety and Tolerability of Nutrifriend Cachexia in NSCLC Cachexia

A 12-week Double Blind, Placebo Controlled, Randomised Pilot Study Assessing Safety and Tolerability of Nutrifriend Cachexia in Patients Diagnosed With Non Small Cell Lung Cancer (NSCLC) With Involuntary Weight Loss

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.

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