ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02515032
Recruitment Status : Completed
First Posted : August 4, 2015
Last Update Posted : July 17, 2017
Sponsor:
Information provided by (Responsible Party):
Smartfish AS

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.

Condition or disease Intervention/treatment Phase
Cachexia NSCLC Dietary Supplement: Nutrifriend Cachexia Dietary Supplement: Isocaloric placebo Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : July 2015
Actual Primary Completion Date : May 2017
Actual Study Completion Date : May 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: NF Cachexia
Nutrifriend Cachexia, an Omega-3 enriched fruit juice (non complete dietary formula).
Dietary Supplement: Nutrifriend Cachexia
2 daily for 12 weeks
Other Name: NFCax

Placebo Comparator: Placebo
An isocaloric placebo comparator
Dietary Supplement: Isocaloric placebo
2 daily for 12 weeks
Other Name: Placobo




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02515032


Locations
Croatia
GH Varaždin
Varaždin, Croatia, 42 000
GH Zadar
Zadar, Croatia, 23 000
CHC Sestre Milosrdnice
Zagreb, Croatia, 10 000
CHC Zagreb,
Zagreb, Croatia, 10 000
Italy
Policlinico Universitario Campus Bio-Medico di Roma
Rome, Italy, 00128
Policlinico Tor Vergata
Rome, Italy, 00133
Azienda Ospedaliera San Camillo Forlanini
Rome, Italy, 00151
Slovakia
FNsP F.D. Roosvelta Banská Bystrica
Banská Bystrica, Slovakia, 975 17
Nemocnica Sv. Jakuba
Bardejov, Slovakia, 085 01
Východoslovenský onkologický ústav
Košice, Slovakia, 041 91
NsP Štefana Kukuru Michalovce
Michalovce, Slovakia, 071 01
FNsP J.A. Reimana
Prešov, Slovakia, 081 81
Sweden
Linkoping University Hospital
Linkoping, Sweden, 58185
Akademiska hospital
Uppsala, Sweden, 751 85
Sponsors and Collaborators
Smartfish AS
Investigators
Principal Investigator: Maurizio Muscaritoli, Prof. University Hospital Sapienza

Responsible Party: Smartfish AS
ClinicalTrials.gov Identifier: NCT02515032     History of Changes
Other Study ID Numbers: SF-C002
First Posted: August 4, 2015    Key Record Dates
Last Update Posted: July 17, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Cachexia
Wasting Syndrome
Emaciation
Weight Loss
Body Weight Changes
Body Weight
Signs and Symptoms
Metabolic Diseases
Nutrition Disorders