CachexiaNCT02515032
Pilot Study of Safety and Tolerability of Nutrifriend Cachexia in NSCLC Cachexia
A study testing Nutrifriend Cachexia in people with Cachexia and NSCLC, run by Smartfish AS at 14 sites in 4 countries.
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. Read more about this study
- Who is it for?
- Any age
- What is being tested?
- Nutrifriend Cachexia
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 14 sitesin 4 countries
- Study dates
- Jul 2015to May 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
14 sites in 4 countries.
14 sites in 4 countries
Slovakia5 sites
FNsP F.D. Roosvelta Banská Bystrica
Banská Bystrica, 975 17
Nemocnica Sv. Jakuba
Bardejov, 085 01
Východoslovenský onkologický ústav
Košice, 041 91
NsP Štefana Kukuru Michalovce
Michalovce, 071 01
FNsP J.A. Reimana
Prešov, 081 81
Croatia4 sites
GH Varaždin
Varaždin, 42 000
GH Zadar
Zadar, 23 000
CHC Sestre Milosrdnice
Zagreb, 10 000
CHC Zagreb,
Zagreb, 10 000
Italy3 sites
Policlinico Universitario Campus Bio-Medico di Roma
Rome, 00128
Policlinico Tor Vergata
Rome, 00133
Azienda Ospedaliera San Camillo Forlanini
Rome, 00151
Sweden2 sites
Linkoping University Hospital
Linköping, 58185
Akademiska hospital
Uppsala, 751 85
About this study
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
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.
Read the 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.
- Being tested
- Nutrifriend Cachexia, Isocaloric placebo
- Medical subject headings
- Cachexia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutrifriend CachexiaDietary supplement
Also called NFCax
2 daily for 12 weeks
Isocaloric placeboDietary supplement
Also called Placobo
2 daily for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| NF Cachexia | Experimental | Nutrifriend Cachexia, an Omega-3 enriched fruit juice (non complete dietary formula). Receives: Dietary Supplement: Nutrifriend Cachexia |
| Placebo | Placebo comparator | An isocaloric placebo comparator Receives: Dietary Supplement: Isocaloric placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability assessed by (adverse events, concomitant medication and laboratory markers) of Nutrifriend Cachexia in patients with NSCLC
Measured: 12 weeks
Secondary outcomes (16)
Body composition assessed by fat mass and lean body mass (LBM)
Measured: 12 weeks
Body composition assessed by weight
Measured: 12 weeks
Body composition assessed by BMI
Measured: 12 weeks
Body composition assessed by waist circumference
Measured: 12 weeks
Body composition assessed by calf circumference
Measured: 12 weeks
Function assessed by 6 minute walking test
Measured: 12 weeks
Function assessed by grip strength
Measured: 12 weeks
Function assessed by walking distance
Measured: 12 weeks
Inflammation
IL-6, IL-8, TNF-alpha, CRP
Measured: 12 weeks
Metabolic markers
Glucose, insulin, cholesterol, HbA1c
Measured: 12 weeks
QoL assessed by EORTC QLQ-C3
Measured: 12 weeks
QoL assessed by Functional Assessment of Anorexia/Cachexia Therapy (FAACT) questionnaire
Measured: 12 weeks
QoL assessed by Nutrition Appetite Questionnaire (CNAQ)
Measured: 12 weeks
Compliance assessed by Drinks consumed
Measured: 12 weeks
Compliance assessed by vitamin D levels
Measured: 12 weeks
Compliance assessed by Omega-3 incorporation
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2015 (estimated)
- Study startJul 2015
- Primary completionMay 2017
- Study completionMay 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CachexiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Smartfish AS
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Maurizio Muscaritoli, Prof., Principal investigator, University Hospital Sapienza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02515032
- Sponsor's protocol ID
- SF-C002
- Status last verified
- Jul 2017
- First submitted
- 28 Jul 2015
- Last updated
- 17 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 31290697
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02515032
- Acronym / sponsor ID
- SF-C002
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Smartfish ASIndustry (pharma, biotech, devices)
- Study start
- Jul 2015 (actual)
- Primary completion
- May 2017 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 4 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NF Cachexia | Experimental | Dietary Supplement: Nutrifriend CachexiaNutrifriend Cachexia, an Omega-3 enriched fruit juice (non complete dietary formula). |
| Placebo | Placebo comparator | Dietary Supplement: Isocaloric placeboAn isocaloric placebo comparator |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nutrifriend CachexiaAlso: NFCax2 daily for 12 weeks | Dietary supplement | NF Cachexia |
| Isocaloric placeboAlso: Placobo2 daily for 12 weeks | Dietary supplement | Placebo |
Primary outcome
Safety and tolerability assessed by (adverse events, concomitant medication and laboratory markers) of Nutrifriend Cachexia in patients with NSCLC
Time frame: 12 weeks
16 secondary outcomes
Body composition assessed by fat mass and lean body mass (LBM)
Time frame: 12 weeks
Body composition assessed by weight
Time frame: 12 weeks
Body composition assessed by BMI
Time frame: 12 weeks
Body composition assessed by waist circumference
Time frame: 12 weeks
Body composition assessed by calf circumference
Time frame: 12 weeks
Function assessed by 6 minute walking test
Time frame: 12 weeks
Function assessed by grip strength
Time frame: 12 weeks
Function assessed by walking distance
Time frame: 12 weeks
Inflammation
Time frame: 12 weeks
Metabolic markers
Time frame: 12 weeks
QoL assessed by EORTC QLQ-C3
Time frame: 12 weeks
QoL assessed by Functional Assessment of Anorexia/Cachexia Therapy (FAACT) questionnaire
Time frame: 12 weeks
QoL assessed by Nutrition Appetite Questionnaire (CNAQ)
Time frame: 12 weeks
Compliance assessed by Drinks consumed
Time frame: 12 weeks
Compliance assessed by vitamin D levels
Time frame: 12 weeks
Compliance assessed by Omega-3 incorporation
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2017.
- Derived from this study: PubMed 31290697Laviano 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maurizio Muscaritoli, Prof. principal investigator
University Hospital Sapienza
14 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutrifriend Cachexia in people with Cachexia and NSCLC, run by Smartfish AS at 14 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Slovakia, Croatia, Italy, Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and tolerability assessed by (adverse events, concomitant medication and laboratory markers) of Nutrifriend Cachexia in patients with NSCLC (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02515032, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2017.