Ignite Creation Date:
2025-12-25 @ 12:27 AM
Ignite Modification Date:
2025-12-25 @ 10:32 PM
Study NCT ID:
NCT01025167
Status:
COMPLETED
Last Update Posted:
2010-08-20
First Post:
2009-12-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effect of a New Specific Enteral Formula Compared to a Standard Formula on the Tolerability of a Combined Radio- and Chemotherapy in Cancer Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005502', 'term': 'Food'}], 'ancestors': [{'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 111}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-08', 'completionDateStruct': {'date': '2010-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-08-19', 'studyFirstSubmitDate': '2009-12-02', 'studyFirstSubmitQcDate': '2009-12-02', 'lastUpdatePostDateStruct': {'date': '2010-08-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-12-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Body cell mass measured by bioelectrical impedance spectroscopy (BIS)', 'timeFrame': 'Baseline, mid of radio-/chemotherapy, end of radio-/chemotherapy, day 28 of convalescence period, day 49 of convalescence period'}], 'secondaryOutcomes': [{'measure': 'Other parameters of body composition such as fat free mass, lipid mass, total body water, intracellular water, lean tissue mass', 'timeFrame': 'Baseline, mid of radio-/chemotherapy, end of radio-/chemotherapy, day 28 of convalescence period, day 49 of convalescence period'}, {'measure': 'Hand grip strength', 'timeFrame': 'Baseline, mid of radio-/chemotherapy, end of radio-/chemotherapy, day 28 of convalescence period, day 49 of convalescence period'}, {'measure': 'Quality of Life', 'timeFrame': 'Baseline, end of radio-/chemotherapy, day 49 of convalescence period'}, {'measure': 'Gastrointestinal tolerance', 'timeFrame': 'Baseline, mid of radio-/chemotherapy, end of radio-/chemotherapy, day 28 of convalescence period, day 49 of convalescence period, daily'}]}, 'conditionsModule': {'keywords': ['cancer', 'enteral nutrition', 'omega-3-fatty acids'], 'conditions': ['Enteral Nutrition']}, 'referencesModule': {'references': [{'pmid': '23765693', 'type': 'DERIVED', 'citation': 'Fietkau R, Lewitzki V, Kuhnt T, Holscher T, Hess CF, Berger B, Wiegel T, Rodel C, Niewald M, Hermann RM, Lubgan D. A disease-specific enteral nutrition formula improves nutritional status and functional performance in patients with head and neck and esophageal cancer undergoing chemoradiotherapy: results of a randomized, controlled, multicenter trial. Cancer. 2013 Sep 15;119(18):3343-53. doi: 10.1002/cncr.28197. Epub 2013 Jun 13.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to determine the impact of a specific nutrition formula with a high content of eicosapentaenoic acid (EPA) and fat in oncology patients receiving radio-/chemotherapy on body weight, body composition, nutritional status and physical function compared to a standard nutrition formula. Using an adaptive design approximately 80 patients will be randomized in the first part of the study. Following an interim analysis further 160 patients may be added, for a total of 240 patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients with head \\& neck cancer or oesophagus cancer,\n* enteral nutrition with PEG at least for 14 weeks,\n* cancer patients who receive a combined radio-/chemotherapy,\n* start of nutritional therapy latest at beginning of the radio-/chemotherapy, body mass index \\>=16 and \\<=30 kg/m2,0\n* Kondrup Score\\>=3 or SGA = B/C,\n* life expectancy \\> 6 months,\n* written informed consent.\n\nExclusion Criteria:\n\n* second active carcinoma,\n* severe diarrhea unresponsive to codeine/loperamide,\n* positive anti-HIV-test (safety reasons),\n* pregnant or lactating women,\n* insulin-dependent diabetes mellitus type I and II,\n* patients with cardiac pacemaker,\n* allergy to contents of the investigational product, to milk protein or to fish oil,\n* patient has no PEG,\n* participation in concurrent clinical studies with any other investigational nutritional therapy within one months prior to start of the study,\n* intake of muscle growth supportan substances (e.g. anabolics),\n* additional fish oil or EPA substitution within the last 4 weeks, SGA status A (well nourished).'}, 'identificationModule': {'nctId': 'NCT01025167', 'briefTitle': 'The Effect of a New Specific Enteral Formula Compared to a Standard Formula on the Tolerability of a Combined Radio- and Chemotherapy in Cancer Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Fresenius Kabi'}, 'orgStudyIdInfo': {'id': 'N-SUP-09-DE'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Test', 'description': 'Supportan(R) (500 ml)/disease-specific enteral tube feed for oncologic patients with special key substrates', 'interventionNames': ['Dietary Supplement: Supportan(R) (Disease-specific enteral tube feed, food for special medical purposes)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control', 'description': 'Fresubin(R) energy fibre (500 ml)/a nutritionally complete enteral standard feed (isoenergetic)', 'interventionNames': ['Dietary Supplement: Fresubin(R)']}], 'interventions': [{'name': 'Supportan(R) (Disease-specific enteral tube feed, food for special medical purposes)', 'type': 'DIETARY_SUPPLEMENT', 'description': '500 ml per day / treatment period 11-14 weeks', 'armGroupLabels': ['Test']}, {'name': 'Fresubin(R)', 'type': 'DIETARY_SUPPLEMENT', 'description': '500 ml/a nutritionally complete enteral standard feed (isoenergetic)', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'D-28239', 'city': 'Bremen', 'country': 'Germany', 'facility': 'Zentrum für Strahlentherapie und Radioonkologie, Ärztehaus am DIAKO', 'geoPoint': {'lat': 53.07582, 'lon': 8.80717}}, {'zip': 'D-01307', 'city': 'Dresden', 'country': 'Germany', 'facility': 'Klinik und Poliklinik für Strahlentherapie und Radioonkologie, Universitätsklinikum Dresden', 'geoPoint': {'lat': 51.05089, 'lon': 13.73832}}, {'zip': 'D-91054', 'city': 'Erlangen', 'country': 'Germany', 'facility': 'Department of Radiotherapy, University hospital', 'geoPoint': {'lat': 49.59099, 'lon': 11.00783}}, {'zip': 'D-60590', 'city': 'Frankfurt', 'country': 'Germany', 'facility': 'Klinik für Strahlentherapie und Radioonkologie, Universitätsklinikum Frankfurt', 'geoPoint': {'lat': 49.68333, 'lon': 10.53333}}, {'zip': 'D-37075', 'city': 'Göttingen', 'country': 'Germany', 'facility': 'Abteilung Strahlentherapie und Radioonkologie, Universitätsmedizin Göttingen', 'geoPoint': {'lat': 51.53443, 'lon': 9.93228}}, {'zip': 'D-06097', 'city': 'Halle', 'country': 'Germany', 'facility': 'Klinik für Strahlentherapie, Universitätsklinikum Halle', 'geoPoint': {'lat': 51.48158, 'lon': 11.97947}}, {'zip': 'D-66421', 'city': 'Homburg (Saar)', 'country': 'Germany', 'facility': 'Klinik für Strahlentherapie und Radioonkologie, Universitätsklinikum des Saarlandes', 'geoPoint': {'lat': 49.32637, 'lon': 7.33867}}, {'zip': 'D-18059', 'city': 'Rostock', 'country': 'Germany', 'facility': 'Klinik und Poliklinik für Strahlentherapie Universität Rostock', 'geoPoint': {'lat': 54.0887, 'lon': 12.14049}}, {'zip': 'D-72076', 'city': 'Tübingen', 'country': 'Germany', 'facility': 'Abteilung Strahlentherapie und Radioonkologie, Universitätsmedizin Tübingen', 'geoPoint': {'lat': 48.52266, 'lon': 9.05222}}, {'zip': 'D-89081', 'city': 'Ulm', 'country': 'Germany', 'facility': 'Klinik für Strahlentherapie und Radioonkologie, Universitätsklinikum Ulm', 'geoPoint': {'lat': 48.39841, 'lon': 9.99155}}], 'overallOfficials': [{'name': 'Rainer Fietkau, Prof. Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Radiotherapy University hospital of Erlangen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fresenius Kabi', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Dr. Steffen Benzing', 'oldOrganization': 'Kabi Innovation Centre, Fresenius Kabi Deutschland GmbH'}}}}