Clinical Trial: Pilot Study of Safety and Tolerability of Nutrifriend Cachexia in NSCLC Cachexia

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: 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 Involunt

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 Summary: 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.
Sponsor: Smartfish AS

Current Primary Outcome: Safety and tolerability assessed by (adverse events, concomitant medication and laboratory markers) of Nutrifriend Cachexia in patients with NSCLC [ Time Frame: 12 weeks ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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 [ Time Frame: 12 weeks ]
    IL-6, IL-8, TNF-alpha, CRP
  • Metabolic markers [ Time Frame: 12 weeks ]
    Glucose, insulin, cholesterol, HbA1c
  • 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 ]


Original Secondary Outcome: Same as current

Information By: Smartfish AS

Dates:
Date Received: July 28, 2015
Date Started: July 2015
Date Completion: August 2017
Last Updated: November 1, 2016
Last Verified: November 2016