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

NSCLC Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02515032
• Other study ID #: SF-C002
• Status: Completed
• Phase: N/A
• First received: July 28, 2015
• Last updated: July 12, 2017
• Start date: July 2015
• Est. completion date: May 2017

Study information

• Verified date: July 2017
• Source: Smartfish AS
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: May 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Cachexia
• NSCLC

Intervention

Dietary Supplement:
• Nutrifriend Cachexia
2 daily for 12 weeks
• Isocaloric placebo
2 daily for 12 weeks

Locations

Country	Name	City	State
Croatia	GH Varaždin	Varaždin
Croatia	GH Zadar	Zadar
Croatia	CHC Sestre Milosrdnice	Zagreb
Croatia	CHC Zagreb,	Zagreb
Italy	Azienda Ospedaliera San Camillo Forlanini	Rome
Italy	Policlinico Tor Vergata	Rome
Italy	Policlinico Universitario Campus Bio-Medico di Roma	Rome
Slovakia	FNsP F.D. Roosvelta Banská Bystrica	Banská Bystrica
Slovakia	Nemocnica Sv. Jakuba	Bardejov
Slovakia	Východoslovenský onkologický ústav	Košice
Slovakia	NsP Štefana Kukuru Michalovce	Michalovce
Slovakia	FNsP J.A. Reimana	Prešov
Sweden	Linkoping University Hospital	Linkoping
Sweden	Akademiska hospital	Uppsala

Sponsors (1)

Lead Sponsor	Collaborator
Smartfish AS

Countries where clinical trial is conducted

Croatia,  Italy,  Slovakia,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Response to chemotherapy by tumor growth		12 weeks
Other	Overall survival		52 weeks
Other	Exploratory biomarkers related to cachexia, e.g. carnosine, beta-alanine		12 weeks
Primary	Safety and tolerability assessed by (adverse events, concomitant medication and laboratory markers) of Nutrifriend Cachexia in patients with NSCLC		12 weeks
Secondary	Body composition assessed by fat mass and lean body mass (LBM)		12 weeks
Secondary	Body composition assessed by weight		12 weeks
Secondary	Body composition assessed by BMI		12 weeks
Secondary	Body composition assessed by waist circumference		12 weeks
Secondary	Body composition assessed by calf circumference		12 weeks
Secondary	Function assessed by 6 minute walking test		12 weeks
Secondary	Function assessed by grip strength		12 weeks
Secondary	Function assessed by walking distance		12 weeks
Secondary	Inflammation	IL-6, IL-8, TNF-alpha, CRP	12 weeks
Secondary	Metabolic markers	Glucose, insulin, cholesterol, HbA1c	12 weeks
Secondary	QoL assessed by EORTC QLQ-C3		12 weeks
Secondary	QoL assessed by Functional Assessment of Anorexia/Cachexia Therapy (FAACT) questionnaire		12 weeks
Secondary	QoL assessed by Nutrition Appetite Questionnaire (CNAQ)		12 weeks
Secondary	Compliance assessed by Drinks consumed		12 weeks
Secondary	Compliance assessed by vitamin D levels		12 weeks
Secondary	Compliance assessed by Omega-3 incorporation		12 weeks