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Completed

NCT Number: NCT02515032

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

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.

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Key information

Conditions

Cachexia Body Weight Body Weight Changes NSCLC Pathological Conditions, Signs and Symptoms Signs and Symptoms Thinness Weight Loss

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

GH Varaždin, Varaždin, Croatia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nutrifriend Cachexia

Dietary Supplement

2 daily for 12 weeks

Other names: NFCax

Isocaloric placebo

Dietary Supplement

2 daily for 12 weeks

Other names: Placobo

Primary outcomes

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

    Time frame: 12 weeks

Secondary outcomes

  1. Body composition assessed by fat mass and lean body mass (LBM)

    Time frame: 12 weeks

  2. Body composition assessed by weight

    Time frame: 12 weeks

  3. Body composition assessed by BMI

    Time frame: 12 weeks

  4. Body composition assessed by waist circumference

    Time frame: 12 weeks

  5. Body composition assessed by calf circumference

    Time frame: 12 weeks

  6. Function assessed by 6 minute walking test

    Time frame: 12 weeks

  7. Function assessed by grip strength

    Time frame: 12 weeks

  8. Function assessed by walking distance

    Time frame: 12 weeks

  9. Inflammation

    Time frame: 12 weeks

    IL-6, IL-8, TNF-alpha, CRP

  10. Metabolic markers

    Time frame: 12 weeks

    Glucose, insulin, cholesterol, HbA1c

  11. QoL assessed by EORTC QLQ-C3

    Time frame: 12 weeks

  12. QoL assessed by Functional Assessment of Anorexia/Cachexia Therapy (FAACT) questionnaire

    Time frame: 12 weeks

  13. QoL assessed by Nutrition Appetite Questionnaire (CNAQ)

    Time frame: 12 weeks

  14. Compliance assessed by Drinks consumed

    Time frame: 12 weeks

  15. Compliance assessed by vitamin D levels

    Time frame: 12 weeks

  16. Compliance assessed by Omega-3 incorporation

    Time frame: 12 weeks

Other outcomes

  1. Response to chemotherapy by tumor growth

    Time frame: 12 weeks

  2. Overall survival

    Time frame: 52 weeks

  3. Exploratory biomarkers related to cachexia, e.g. carnosine, beta-alanine

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

Smartfish AS

Industry

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Aug 4, 2015
Registry last updated
Jul 17, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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