NCT02515032

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: Smartfish AS · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Cachexia
• NSCLC

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Nutrifriend Cachexia	2 daily for 12 weeks
DIETARY_SUPPLEMENT	Isocaloric placebo	2 daily for 12 weeks

Timeline

• Start date: 2015-07-01
• Primary completion: 2017-05-01
• Completion: 2017-05-01
• First posted: 2015-08-04
• Last updated: 2017-07-17

Locations

14 sites across 4 countries: Croatia, Italy, Slovakia, Sweden