Ignite Creation Date:
2025-12-24 @ 9:59 PM
Ignite Modification Date:
2026-03-28 @ 10:25 AM
Study NCT ID:
NCT02515032
Status:
COMPLETED
Last Update Posted:
2017-07-17
First Post:
2015-07-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pilot Study of Safety and Tolerability of Nutrifriend Cachexia in NSCLC Cachexia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002100', 'term': 'Cachexia'}], 'ancestors': [{'id': 'D015431', 'term': 'Weight Loss'}, {'id': 'D001836', 'term': 'Body Weight Changes'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D013851', 'term': 'Thinness'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 56}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-07', 'completionDateStruct': {'date': '2017-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-07-12', 'studyFirstSubmitDate': '2015-07-28', 'studyFirstSubmitQcDate': '2015-07-30', 'lastUpdatePostDateStruct': {'date': '2017-07-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-08-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Response to chemotherapy by tumor growth', 'timeFrame': '12 weeks'}, {'measure': 'Overall survival', 'timeFrame': '52 weeks'}, {'measure': 'Exploratory biomarkers related to cachexia, e.g. carnosine, beta-alanine', 'timeFrame': '12 weeks'}], 'primaryOutcomes': [{'measure': 'Safety and tolerability assessed by (adverse events, concomitant medication and laboratory markers) of Nutrifriend Cachexia in patients with NSCLC', 'timeFrame': '12 weeks'}], 'secondaryOutcomes': [{'measure': 'Body composition assessed by fat mass and lean body mass (LBM)', 'timeFrame': '12 weeks'}, {'measure': 'Body composition assessed by weight', 'timeFrame': '12 weeks'}, {'measure': 'Body composition assessed by BMI', 'timeFrame': '12 weeks'}, {'measure': 'Body composition assessed by waist circumference', 'timeFrame': '12 weeks'}, {'measure': 'Body composition assessed by calf circumference', 'timeFrame': '12 weeks'}, {'measure': 'Function assessed by 6 minute walking test', 'timeFrame': '12 weeks'}, {'measure': 'Function assessed by grip strength', 'timeFrame': '12 weeks'}, {'measure': 'Function assessed by walking distance', 'timeFrame': '12 weeks'}, {'measure': 'Inflammation', 'timeFrame': '12 weeks', 'description': 'IL-6, IL-8, TNF-alpha, CRP'}, {'measure': 'Metabolic markers', 'timeFrame': '12 weeks', 'description': 'Glucose, insulin, cholesterol, HbA1c'}, {'measure': 'QoL assessed by EORTC QLQ-C3', 'timeFrame': '12 weeks'}, {'measure': 'QoL assessed by Functional Assessment of Anorexia/Cachexia Therapy (FAACT) questionnaire', 'timeFrame': '12 weeks'}, {'measure': 'QoL assessed by Nutrition Appetite Questionnaire (CNAQ)', 'timeFrame': '12 weeks'}, {'measure': 'Compliance assessed by Drinks consumed', 'timeFrame': '12 weeks'}, {'measure': 'Compliance assessed by vitamin D levels', 'timeFrame': '12 weeks'}, {'measure': 'Compliance assessed by Omega-3 incorporation', 'timeFrame': '12 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Cachexia', 'NSCLC']}, 'referencesModule': {'references': [{'pmid': '31290697', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* First-line standard chemotherapy as curative or palliative treatment for NSCLC\n* Will start the first cycle of standard chemotherapy\n* Eastern Cooperative Oncology Group (ECOG) performance status of ≤2\n* Involuntary weight loss\n\nExclusion Criteria:\n\n* Another invasive malignancy in the last 2 years.\n* Previous relapse of NSCLC within 2 years of randomisation\n* Other cachectic disorders such as renal or hepatic disorders'}, 'identificationModule': {'nctId': 'NCT02515032', 'briefTitle': 'Pilot Study of Safety and Tolerability of Nutrifriend Cachexia in NSCLC Cachexia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Smartfish AS'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'SF-C002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'NF Cachexia', 'description': 'Nutrifriend Cachexia, an Omega-3 enriched fruit juice (non complete dietary formula).', 'interventionNames': ['Dietary Supplement: Nutrifriend Cachexia']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'An isocaloric placebo comparator', 'interventionNames': ['Dietary Supplement: Isocaloric placebo']}], 'interventions': [{'name': 'Nutrifriend Cachexia', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['NFCax'], 'description': '2 daily for 12 weeks', 'armGroupLabels': ['NF Cachexia']}, {'name': 'Isocaloric placebo', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Placobo'], 'description': '2 daily for 12 weeks', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '42 000', 'city': 'Varaždin', 'country': 'Croatia', 'facility': 'GH Varaždin', 'geoPoint': {'lat': 46.30444, 'lon': 16.33778}}, {'zip': '23 000', 'city': 'Zadar', 'country': 'Croatia', 'facility': 'GH Zadar', 'geoPoint': {'lat': 44.11578, 'lon': 15.22514}}, {'zip': '10 000', 'city': 'Zagreb', 'country': 'Croatia', 'facility': 'CHC Sestre Milosrdnice', 'geoPoint': {'lat': 45.81444, 'lon': 15.97798}}, {'zip': '10 000', 'city': 'Zagreb', 'country': 'Croatia', 'facility': 'CHC Zagreb,', 'geoPoint': {'lat': 45.81444, 'lon': 15.97798}}, {'zip': '00128', 'city': 'Rome', 'country': 'Italy', 'facility': 'Policlinico Universitario Campus Bio-Medico di Roma', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}, {'zip': '00133', 'city': 'Rome', 'country': 'Italy', 'facility': 'Policlinico Tor Vergata', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}, {'zip': '00151', 'city': 'Rome', 'country': 'Italy', 'facility': 'Azienda Ospedaliera San Camillo Forlanini', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}, {'zip': '975 17', 'city': 'Banská Bystrica', 'country': 'Slovakia', 'facility': 'FNsP F.D. Roosvelta Banská Bystrica', 'geoPoint': {'lat': 48.73947, 'lon': 19.14932}}, {'zip': '085 01', 'city': 'Bardejov', 'country': 'Slovakia', 'facility': 'Nemocnica Sv. Jakuba', 'geoPoint': {'lat': 49.29175, 'lon': 21.27271}}, {'zip': '041 91', 'city': 'Košice', 'country': 'Slovakia', 'facility': 'Východoslovenský onkologický ústav', 'geoPoint': {'lat': 48.71441, 'lon': 21.25802}}, {'zip': '071 01', 'city': 'Michalovce', 'country': 'Slovakia', 'facility': 'NsP Štefana Kukuru Michalovce', 'geoPoint': {'lat': 48.75434, 'lon': 21.9195}}, {'zip': '081 81', 'city': 'Prešov', 'country': 'Slovakia', 'facility': 'FNsP J.A. Reimana', 'geoPoint': {'lat': 48.99923, 'lon': 21.2355}}, {'zip': '58185', 'city': 'Linköping', 'country': 'Sweden', 'facility': 'Linkoping University Hospital', 'geoPoint': {'lat': 58.41086, 'lon': 15.62157}}, {'zip': '751 85', 'city': 'Uppsala', 'country': 'Sweden', 'facility': 'Akademiska hospital', 'geoPoint': {'lat': 59.85882, 'lon': 17.63889}}], 'overallOfficials': [{'name': 'Maurizio Muscaritoli, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital Sapienza'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Smartfish AS', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}