Clinical trial NCT02515032: 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
Overall status: COMPLETED
Phase: NA
Conditions: Cachexia
NSCLC
Lead sponsor: Smartfish AS
Sponsor class: INDUSTRY
First posted: 2015-08-04
Enrollment: 56
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Safety and tolerability assessed by (adverse events, concomitant medication and laboratory markers) of Nutrifriend Cachexia in patients with NSCLC
timeFrame: 12 weeks
Secondary outcomes:
measure: Body composition assessed by fat mass and lean body mass (LBM)
timeFrame: 12 weeks
measure: Body composition assessed by weight
timeFrame: 12 weeks
measure: Body composition assessed by BMI
timeFrame: 12 weeks
measure: Body composition assessed by waist circumference
timeFrame: 12 weeks
measure: Body composition assessed by calf circumference
timeFrame: 12 weeks
measure: Function assessed by 6 minute walking test
timeFrame: 12 weeks
measure: Function assessed by grip strength
timeFrame: 12 weeks
measure: Function assessed by walking distance
timeFrame: 12 weeks
measure: Inflammation
timeFrame: 12 weeks
measure: Metabolic markers
timeFrame: 12 weeks
measure: QoL assessed by EORTC QLQ-C3
timeFrame: 12 weeks
measure: QoL assessed by Functional Assessment of Anorexia/Cachexia Therapy (FAACT) questionnaire
timeFrame: 12 weeks
measure: QoL assessed by Nutrition Appetite Questionnaire (CNAQ)
timeFrame: 12 weeks
measure: Compliance assessed by Drinks consumed
timeFrame: 12 weeks
measure: Compliance assessed by vitamin D levels
timeFrame: 12 weeks
measure: Compliance assessed by Omega-3 incorporation
timeFrame: 12 weeks
Other outcomes:
measure: Response to chemotherapy by tumor growth
timeFrame: 12 weeks
measure: Overall survival
timeFrame: 52 weeks
measure: Exploratory biomarkers related to cachexia, e.g. carnosine, beta-alanine
timeFrame: 12 weeks
Locations:
city: Varaždin
country: Croatia
facility: GH Varaždin
city: Zadar
country: Croatia
facility: GH Zadar
city: Zagreb
country: Croatia
facility: CHC Sestre Milosrdnice
city: Zagreb
country: Croatia
facility: CHC Zagreb,
city: Rome
country: Italy
facility: Policlinico Universitario Campus Bio-Medico di Roma
city: Rome
country: Italy
facility: Policlinico Tor Vergata
city: Rome
country: Italy
facility: Azienda Ospedaliera San Camillo Forlanini
city: Banská Bystrica
country: Slovakia
facility: FNsP F.D. Roosvelta Banská Bystrica
city: Bardejov
country: Slovakia
facility: Nemocnica Sv. Jakuba
city: Košice
country: Slovakia
facility: Východoslovenský onkologický ústav
city: Michalovce
country: Slovakia
facility: NsP Štefana Kukuru Michalovce
city: Prešov
country: Slovakia
facility: FNsP J.A. Reimana
city: Linkoping
country: Sweden
facility: Linkoping University Hospital
city: Uppsala
country: Sweden
facility: Akademiska hospital
Study officials:
affiliation: University Hospital Sapienza
name: Maurizio Muscaritoli, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
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.