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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Cachexia, NSCLC

Intervention / Treatment
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* Dietary Supplement: Nutrifriend Cachexia
* Dietary Supplement: Isocaloric placebo


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | 
| 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 | 
| 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 | 
| Metabolic markers | Glucose, insulin, cholesterol, HbA1c | 12 weeks | 
| QoL assessed by EORTC QLQ-C3 |  | 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 |