Ignite Creation Date:
2025-12-24 @ 2:22 PM
Ignite Modification Date:
2025-12-30 @ 5:06 AM
Study NCT ID:
NCT01693159
Status:
UNKNOWN
Last Update Posted:
2017-09-25
First Post:
2012-09-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of ECA on Quality of Life in Head and Neck Cancer Patients Suffering From Cetuximab-induced Rhagades
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009824', 'term': 'Ointments'}], 'ancestors': [{'id': 'D004304', 'term': 'Dosage Forms'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2011-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-09', 'completionDateStruct': {'date': '2018-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-09-22', 'studyFirstSubmitDate': '2012-09-18', 'studyFirstSubmitQcDate': '2012-09-21', 'lastUpdatePostDateStruct': {'date': '2017-09-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-09-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'SUPO-Score for classification of cetuximab-induced rhagades', 'timeFrame': '24 hours and 5 to 7 days after application of treatment', 'description': 'SUPO-Score for classification of cetuximab-induced rhagades:\n\nGrade 1: Rhagades without clinical symptoms\n\nGrade 2: Painful rhagades Grade 2a: Moderate pain, no impairment of activity in the daily routine (ADL) Grade 2b: Severe pain and impairment of the activities of daily living (ADL) Grade 3: Painful, deep and spontaneously bleeding rhagades\n\nGrade 4: Superinfection of the rhagades (detection of bacterial growth) Grade 4a: Local infection Grade 4b: Systemic infection\n\nGrade 5: Death due to complications of the rhagades'}, {'measure': 'Adverse Events of ECA', 'timeFrame': 'from time of randomization untio end of study, i.e. until 5 to 7 days after application of treatment', 'description': 'Adverse Events of ECA due to NCI CTCAE v. 4.02'}], 'primaryOutcomes': [{'measure': 'pain intensity 24 hours after application of ECA or the standard treatment quantified by the visual analogue scale (VAS)', 'timeFrame': '24 hours after application', 'description': 'pain intensity quantified by the visual analogue scale (VAS)'}], 'secondaryOutcomes': [{'measure': 'Evaluation of QoL', 'timeFrame': '5 to 7 days after application of treatment', 'description': 'Evaluation of QoL assessed by the EORTC-QoL-C30 questionnaire and the Dermatological Life Quality Index (DLQI)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Painful cetuximab-induced rhagades', 'Radioimmunotherapy', 'Head and neck cancer'], 'conditions': ['Pain']}, 'referencesModule': {'references': [{'pmid': '24742019', 'type': 'DERIVED', 'citation': 'Potthoff K, Habl G, Bruckner T, Suppan C, Hassel J, Jager D, Indorf M, Debus J. Randomized controlled trial to evaluate the effects of ethyl-2-cyanoacrylate on pain intensity and quality of life in head and neck cancer patients suffering from cetuximab-induced rhagades during radioimmunotherapy: the support trial. BMC Cancer. 2014 Apr 17;14:270. doi: 10.1186/1471-2407-14-270.'}]}, 'descriptionModule': {'briefSummary': 'The SUPPORT trial is an open-label, prospective, randomized, national multicenter intervention study to evaluate the effectiveness of ethyl-2-cyanoacrylate versus the standard treatment of each institution on the pain intensity and QoL in patients with locally advanced head and neck cancer suffering from painful cetuximab-induced rhagades during radioimmunotherapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Locally advanced squamous cell carcinoma of the head and neck and participation in the HICARE-phase-IV-trial\n* Cetuximab-induced painful rhagades, i.e. SUPO Score 2-3 (see Figure 2)\n* Compliance to the photo documentation\n* Ability of subject to understand character and individual consequences of the clinical trial\n* Written informed consent\n\nExclusion Criteria:\n\n* Cetuximab-induced rhagades without any pain, i.e. SUPO Score 1\n* Cetuximab-induced rhagades, SUPO Score 4, i.e. superinfection of the rhagades\n* Patients not being enrolled in the HICARE trial\n* Substance misuse, psychoactive substance abuse or psychological/social conditions leading to a decreased patients' compliance with possible bad influence to the results of the study\n* Known allergic reaction to ethyl-2-cyanoacrylate (ECA)"}, 'identificationModule': {'nctId': 'NCT01693159', 'acronym': 'SUPPORT', 'briefTitle': 'Effects of ECA on Quality of Life in Head and Neck Cancer Patients Suffering From Cetuximab-induced Rhagades', 'organization': {'class': 'OTHER', 'fullName': 'National Center for Tumor Diseases, Heidelberg'}, 'officialTitle': 'Randomized Controlled Multicenter Trial to Evaluate the Effects of Ethyl-2-cyanoacrylate on Pain Intensity and Quality of Life in Head and Neck Cancer Patients Suffering From Cetuximab-induced Rhagades During Radioimmunotherapy', 'orgStudyIdInfo': {'id': 'Uni-HD-2010-33-40-1003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ECA: Ethyl-2-cyanoacrate', 'description': 'Application of ethyl-2-cyanoacrylate (ECA) for painful cetuximab-induced rhagades', 'interventionNames': ['Device: ECA']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard treatment of the institution', 'description': 'Standard treatment of the institution to treat painful cetuximab-induced rhagades', 'interventionNames': ['Other: Standard topical treatment of the institution, e.g. Lotio']}], 'interventions': [{'name': 'ECA', 'type': 'DEVICE', 'otherNames': ['Ethyl-2-cyanoacrylate (ECA)'], 'description': 'In the experimental arm patients will be topically treated with the liquid glue ethyl-2-cyanoacrylate (ECA).', 'armGroupLabels': ['ECA: Ethyl-2-cyanoacrate']}, {'name': 'Standard topical treatment of the institution, e.g. Lotio', 'type': 'OTHER', 'otherNames': ['Ointment, Creme, Lotio, for example dexpanthenol-containing topical treatment'], 'description': 'Standard treatment of the institution to treat painful cetuximab-induced rhagades', 'armGroupLabels': ['Standard treatment of the institution']}]}, 'contactsLocationsModule': {'locations': [{'zip': '69120', 'city': 'Heidelberg', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Karin Potthoff, MD', 'role': 'CONTACT', 'email': 'karin.potthoff@med.uni-heidelberg.de', 'phone': '+496221568201'}, {'name': 'Matthias Haefner, MD', 'role': 'CONTACT', 'email': 'matthias.haefner@med.uni-heidelberg.de', 'phone': '+496221568201'}, {'name': 'Karin Potthoff, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Matthias Haefner, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Juergen Debus, Prof. Dr. Dr.', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'University of Heidelberg Medical Center', 'geoPoint': {'lat': 49.40768, 'lon': 8.69079}}], 'centralContacts': [{'name': 'Karin Potthoff, Dr.', 'role': 'CONTACT', 'email': 'karin.potthoff@med.uni-heidelberg.de', 'phone': '+496221568201'}, {'name': 'Martin Indorf, Dr.', 'role': 'CONTACT', 'email': 'martin.indorf@iomedico.com', 'phone': '+497611524257'}], 'overallOfficials': [{'name': 'Karin Potthoff, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Center for Tumor Diseases, Heidelberg'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Center for Tumor Diseases, Heidelberg', 'class': 'OTHER'}, 'collaborators': [{'name': 'Heidelberg University', 'class': 'OTHER'}, {'name': 'iOMEDICO AG', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}