Trial record 6 of 9 for:
smartfish
Pilot Study of Safety and Tolerability of Nutrifriend Cachexia in NSCLC Cachexia
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| ClinicalTrials.gov Identifier: NCT02515032 |
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Recruitment Status :
Completed
First Posted : August 4, 2015
Last Update Posted : July 17, 2017
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Sponsor:
Smartfish AS
Information provided by (Responsible Party):
Smartfish AS
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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 |
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
MedlinePlus Genetics related topics:
Lung cancer
| Arm | Intervention/treatment |
|---|---|
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Experimental: NF Cachexia
Nutrifriend Cachexia, an Omega-3 enriched fruit juice (non complete dietary formula).
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Dietary Supplement: Nutrifriend Cachexia
2 daily for 12 weeks
Other Name: NFCax |
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Placebo Comparator: Placebo
An isocaloric placebo comparator
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Dietary Supplement: Isocaloric placebo
2 daily for 12 weeks
Other Name: Placobo |
Primary Outcome Measures :
- 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 :
- 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 ]IL-6, IL-8, TNF-alpha, CRP
- Metabolic markers [ Time Frame: 12 weeks ]Glucose, insulin, cholesterol, HbA1c
- 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 ]
Other Outcome Measures:
- Response to chemotherapy by tumor growth [ Time Frame: 12 weeks ]
- Overall survival [ Time Frame: 52 weeks ]
- Exploratory biomarkers related to cachexia, e.g. carnosine, beta-alanine [ Time Frame: 12 weeks ]
Information from the National Library of Medicine
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| 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 |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Smartfish AS |
| ClinicalTrials.gov Identifier: | NCT02515032 |
| 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:
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Wasting Syndrome Cachexia Emaciation Weight Loss |
Body Weight Changes Body Weight Metabolic Diseases Nutrition Disorders |