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.

Study Overview

• Status: Completed
• Conditions: NSCLC; Cachexia
• Intervention / Treatment: Dietary supplement: Nutrifriend Cachexia; Dietary supplement: Isocaloric placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 56
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Croatia
  • Varaždin, Croatia, 42 000
    • GH Varaždin
  • Zadar, Croatia, 23 000
    • GH Zadar
  • Zagreb, Croatia, 10 000
    • CHC Sestre milosrdnice
  • Zagreb, Croatia, 10 000
    • CHC Zagreb,
• Italy
  • Rome, Italy, 00133
    • Policlinico Tor Vergata
  • Rome, Italy, 00151
    • Azienda Ospedaliera San Camillo Forlanini
  • Rome, Italy, 00128
    • Policlinico Universitario Campus Bio-Medico di Roma
• Slovakia
  • Banská Bystrica, Slovakia, 975 17
    • FNsP F.D. Roosvelta Banská Bystrica
  • Bardejov, Slovakia, 085 01
    • Nemocnica Sv. Jakuba
  • Košice, Slovakia, 041 91
    • Vychodoslovensky onkologicky ustav
  • Michalovce, Slovakia, 071 01
    • NsP Štefana Kukuru Michalovce
  • Prešov, Slovakia, 081 81
    • FNsP J.A. Reimana
• Sweden
  • Linkoping, Sweden, 58185
    • Linköping University Hospital
  • Uppsala, Sweden, 751 85
    • Akademiska hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: NF Cachexia; Nutrifriend Cachexia, an Omega-3 enriched fruit juice (non complete dietary formula).	Dietary supplement: Nutrifriend Cachexia; 2 daily for 12 weeks; Other Names: NFCax
Placebo Comparator: Placebo; An isocaloric placebo comparator	Dietary supplement: Isocaloric placebo; 2 daily for 12 weeks; Other Names: Placobo

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body composition assessed by fat mass and lean body mass (LBM)		12 weeks
Function assessed by 6 minute walking test		12 weeks
Function assessed by grip strength		12 weeks
Function assessed by walking distance		12 weeks
Inflammation	IL-6, IL-8, TNF-alpha, CRP	12 weeks
QoL assessed by Functional Assessment of Anorexia/Cachexia Therapy (FAACT) questionnaire		12 weeks
QoL assessed by Nutrition Appetite Questionnaire (CNAQ)		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 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
Metabolic markers	Glucose, insulin, cholesterol, HbA1c	12 weeks
QoL assessed by EORTC QLQ-C3		12 weeks

Other Outcome Measures

Outcome Measure	Time Frame
Response to chemotherapy by tumor growth	12 weeks
Overall survival	52 weeks
Exploratory biomarkers related to cachexia, e.g. carnosine, beta-alanine	12 weeks

Collaborators and Investigators

• Sponsor: Smartfish AS
• Investigators: Principal Investigator: Maurizio Muscaritoli, Prof., University Hospital Sapienza

Publications and helpful links

General Publications

• Laviano A, Calder PC, Schols AMWJ, Lonnqvist F, Bech M, Muscaritoli M. Safety and Tolerability of Targeted Medical Nutrition for Cachexia in Non-Small-Cell Lung Cancer: A Randomized, Double-Blind, Controlled Pilot Trial. Nutr Cancer. 2020;72(3):439-450. doi: 10.1080/01635581.2019.1634746. Epub 2019 Jul 10.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2015
• Primary Completion (Actual): May 1, 2017
• Study Completion (Actual): May 1, 2017

Study Registration Dates

• First Submitted: July 28, 2015
• First Submitted That Met QC Criteria: July 30, 2015
• First Posted (Estimate): August 4, 2015

Study Record Updates

• Last Update Posted (Actual): July 17, 2017
• Last Update Submitted That Met QC Criteria: July 12, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Nutrition Disorders; Body Weight; Body Weight Changes; Emaciation; Weight Loss; Wasting Syndrome; Cachexia
• Other Study ID Numbers: SF-C002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED