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

Primary Purpose

Cachexia, NSCLC

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Nutrifriend Cachexia
Isocaloric placebo
Sponsored by
Smartfish AS
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cachexia

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • GH Varaždin
  • GH Zadar
  • CHC Sestre Milosrdnice
  • CHC Zagreb,
  • Policlinico Universitario Campus Bio-Medico di Roma
  • Policlinico Tor Vergata
  • Azienda Ospedaliera San Camillo Forlanini
  • FNsP F.D. Roosvelta Banská Bystrica
  • Nemocnica Sv. Jakuba
  • Východoslovenský onkologický ústav
  • NsP Štefana Kukuru Michalovce
  • FNsP J.A. Reimana
  • Linkoping University Hospital
  • Akademiska hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

NF Cachexia

Placebo

Arm Description

Nutrifriend Cachexia, an Omega-3 enriched fruit juice (non complete dietary formula).

An isocaloric placebo comparator

Outcomes

Primary Outcome Measures

Safety and tolerability assessed by (adverse events, concomitant medication and laboratory markers) of Nutrifriend Cachexia in patients with NSCLC

Secondary Outcome Measures

Body composition assessed by fat mass and lean body mass (LBM)
Body composition assessed by weight
Body composition assessed by BMI
Body composition assessed by waist circumference
Body composition assessed by calf circumference
Function assessed by 6 minute walking test
Function assessed by grip strength
Function assessed by walking distance
Inflammation
IL-6, IL-8, TNF-alpha, CRP
Metabolic markers
Glucose, insulin, cholesterol, HbA1c
QoL assessed by EORTC QLQ-C3
QoL assessed by Functional Assessment of Anorexia/Cachexia Therapy (FAACT) questionnaire
QoL assessed by Nutrition Appetite Questionnaire (CNAQ)
Compliance assessed by Drinks consumed
Compliance assessed by vitamin D levels
Compliance assessed by Omega-3 incorporation

Full Information

First Posted
July 28, 2015
Last Updated
July 12, 2017
Sponsor
Smartfish AS
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1. Study Identification

Unique Protocol Identification Number
NCT02515032
Brief Title
Pilot Study of Safety and Tolerability of Nutrifriend Cachexia in NSCLC Cachexia
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 Involuntary Weight Loss
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
July 2015 (Actual)
Primary Completion Date
May 2017 (Actual)
Study Completion Date
May 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Smartfish AS

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cachexia, NSCLC

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
56 (Actual)

8. Arms, Groups, and Interventions

Arm Title
NF Cachexia
Arm Type
Experimental
Arm Description
Nutrifriend Cachexia, an Omega-3 enriched fruit juice (non complete dietary formula).
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
An isocaloric placebo comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
Nutrifriend Cachexia
Other Intervention Name(s)
NFCax
Intervention Description
2 daily for 12 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Isocaloric placebo
Other Intervention Name(s)
Placobo
Intervention Description
2 daily for 12 weeks
Primary Outcome Measure Information:
Title
Safety and tolerability assessed by (adverse events, concomitant medication and laboratory markers) of Nutrifriend Cachexia in patients with NSCLC
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Body composition assessed by fat mass and lean body mass (LBM)
Time Frame
12 weeks
Title
Body composition assessed by weight
Time Frame
12 weeks
Title
Body composition assessed by BMI
Time Frame
12 weeks
Title
Body composition assessed by waist circumference
Time Frame
12 weeks
Title
Body composition assessed by calf circumference
Time Frame
12 weeks
Title
Function assessed by 6 minute walking test
Time Frame
12 weeks
Title
Function assessed by grip strength
Time Frame
12 weeks
Title
Function assessed by walking distance
Time Frame
12 weeks
Title
Inflammation
Description
IL-6, IL-8, TNF-alpha, CRP
Time Frame
12 weeks
Title
Metabolic markers
Description
Glucose, insulin, cholesterol, HbA1c
Time Frame
12 weeks
Title
QoL assessed by EORTC QLQ-C3
Time Frame
12 weeks
Title
QoL assessed by Functional Assessment of Anorexia/Cachexia Therapy (FAACT) questionnaire
Time Frame
12 weeks
Title
QoL assessed by Nutrition Appetite Questionnaire (CNAQ)
Time Frame
12 weeks
Title
Compliance assessed by Drinks consumed
Time Frame
12 weeks
Title
Compliance assessed by vitamin D levels
Time Frame
12 weeks
Title
Compliance assessed by Omega-3 incorporation
Time Frame
12 weeks
Other Pre-specified Outcome Measures:
Title
Response to chemotherapy by tumor growth
Time Frame
12 weeks
Title
Overall survival
Time Frame
52 weeks
Title
Exploratory biomarkers related to cachexia, e.g. carnosine, beta-alanine
Time Frame
12 weeks

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maurizio Muscaritoli, Prof.
Organizational Affiliation
University Hospital Sapienza
Official's Role
Principal Investigator
Facility Information:
Facility Name
GH Varaždin
City
Varaždin
ZIP/Postal Code
42 000
Country
Croatia
Facility Name
GH Zadar
City
Zadar
ZIP/Postal Code
23 000
Country
Croatia
Facility Name
CHC Sestre Milosrdnice
City
Zagreb
ZIP/Postal Code
10 000
Country
Croatia
Facility Name
CHC Zagreb,
City
Zagreb
ZIP/Postal Code
10 000
Country
Croatia
Facility Name
Policlinico Universitario Campus Bio-Medico di Roma
City
Rome
ZIP/Postal Code
00128
Country
Italy
Facility Name
Policlinico Tor Vergata
City
Rome
ZIP/Postal Code
00133
Country
Italy
Facility Name
Azienda Ospedaliera San Camillo Forlanini
City
Rome
ZIP/Postal Code
00151
Country
Italy
Facility Name
FNsP F.D. Roosvelta Banská Bystrica
City
Banská Bystrica
ZIP/Postal Code
975 17
Country
Slovakia
Facility Name
Nemocnica Sv. Jakuba
City
Bardejov
ZIP/Postal Code
085 01
Country
Slovakia
Facility Name
Východoslovenský onkologický ústav
City
Košice
ZIP/Postal Code
041 91
Country
Slovakia
Facility Name
NsP Štefana Kukuru Michalovce
City
Michalovce
ZIP/Postal Code
071 01
Country
Slovakia
Facility Name
FNsP J.A. Reimana
City
Prešov
ZIP/Postal Code
081 81
Country
Slovakia
Facility Name
Linkoping University Hospital
City
Linkoping
ZIP/Postal Code
58185
Country
Sweden
Facility Name
Akademiska hospital
City
Uppsala
ZIP/Postal Code
751 85
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
31290697
Citation
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.
Results Reference
derived

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

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