Ignite Creation Date:
2025-12-25 @ 3:47 AM
Ignite Modification Date:
2025-12-26 @ 2:34 AM
Study NCT ID:
NCT01598402
Status:
UNKNOWN
Last Update Posted:
2013-07-15
First Post:
2012-02-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy of Prophylactic Treatment With Antibiotics During Concomitant Chemoradiotherapy in Patients With Head and Neck Cancer to Prevent Aspiration Pneumonia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006258', 'term': 'Head and Neck Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000658', 'term': 'Amoxicillin'}], 'ancestors': [{'id': 'D000667', 'term': 'Ampicillin'}, {'id': 'D010400', 'term': 'Penicillin G'}, {'id': 'D010406', 'term': 'Penicillins'}, {'id': 'D047090', 'term': 'beta-Lactams'}, {'id': 'D007769', 'term': 'Lactams'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 106}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2011-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-07', 'completionDateStruct': {'date': '2014-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-07-12', 'studyFirstSubmitDate': '2012-02-02', 'studyFirstSubmitQcDate': '2012-05-14', 'lastUpdatePostDateStruct': {'date': '2013-07-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-05-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the number of definite pneumonia and/ or suspected pneumonia', 'timeFrame': 'from day 1 of 1 CRT until 3,5 mnd after the last CRT', 'description': 'Definite pneumonia:\n\nEvidence of pneumonia on chest radiography or 3 or more of the following:\n\nSustained fever (temperature\\> 100 f \\[38°C\\]), Rales or rhonchi on chest auscultation Sputum Gram stain showing substantial leukocytes Sputum culture showing a respiratory pathogen\n\nSuspected pneumonia:\n\nAt least 2 of the 4 following features are present, without evidence of pneumonia on chest radiography:\n\nSustained fever (temperature\\> 100 f \\[38°C\\]) Rales or rhonchi on chest auscultation Sputum Gram stain showing substantial leukocytes Sputum culture showing a respiratory pathogen'}], 'secondaryOutcomes': [{'measure': 'effects on Quality of Life', 'timeFrame': 'Baseline, Day 28 last day of CRT, 3,5 months after CRT', 'description': 'to investigate the effects on QoL after prophylactic treatment with antibiotics\n\nPatients fill in the following questionnaires:\n\nQLQ-C30, EORTC H\\&N35, PSHHN, EQ-5D and the VAS, SF-36'}, {'measure': 'Number and kind of positive blood cultures', 'timeFrame': 'from day 1 of 1 CRT until 3,5 mnd after the last CRT'}, {'measure': 'number of admissions to hospital', 'timeFrame': 'from day 1 of 1 CRT until 3,5 mnd after the last CRT'}, {'measure': 'Number of days of admission', 'timeFrame': 'from day 1 of 1 CRT until 3,5 mnd after the last CRT'}, {'measure': 'Effects on mortality', 'timeFrame': 'from day 1 of 1 CRT until 3,5 mnd after the last CRT', 'description': 'Mortality due to definite and/or suspected pneumonia'}, {'measure': 'effects on mucositis: grade and duration', 'timeFrame': 'from day 1 of 1 CRT until 3,5 mnd after the last CRT', 'description': 'Mucositis grade according to CTCAE v.4.0 and duration'}, {'measure': 'side effects of amoxicillin/clavulanic acid', 'timeFrame': 'from day 1 of 1 CRT until 3,5 mnd after the last CRT', 'description': 'side effects of amoxicillin/clavulanic acid'}, {'measure': 'Effects on numbers and causative agents of infections at other sites', 'timeFrame': 'during follow up', 'description': 'numbers and causative agents of infections at other sites during follow up (3.5 months after the end of CRT)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['LAHNC', 'Locally Advanced Head and Neck Cancer'], 'conditions': ['Head and Neck Cancer']}, 'descriptionModule': {'briefSummary': 'Patients with locally advanced head and neck cancer treated with chemo-radiotherapy have (during and shortly after this treatment) a high risk of developing pneumonia by aspiration. This pneumonia is often associated with a hospital admission and affects the quality of life.\n\nThe purpose of the study, is to determine whether prophylactic antibiotics may decrease the development of pneumonia. Prophylactic antibiotics means that there are no signs of pneumonia are already', 'detailedDescription': 'Concomitant chemoradiotherapy (CRT) is used in locally advanced head and neck cancer (LAHNC). It will be administered to patients for unresectable disease or for organ preservation as primary treatment. Furthermore, it can be used as postoperative treatment in case high risk recurrent disease is present. This treatment induces a high rate of acute toxicity, such as mucositis, dermatitis, dysphagia, anorexia, and pain. Swallowing dysfunction and aspiration are seen in a high proportion (30%-100%) of patients and with an immense impact on Quality of life (QoL).\n\nAround half of the patients will develop an aspiration pneumonia during or shortly after the treatment.\n\nPatients, who develop fever during concomitant chemoradiotherapy, are most of the time admitted in the hospital. In the differential diagnosis pneumonia is on the first place in all those patients. The standard diagnostic procedures consist of a chest X-ray and culture of the sputum and blood. Pneumonia can lead to mortality in this frail patient group.\n\nThe treatment of patients treated with chemoradiotherapy who develop fever and have a definite or suspected pneumonia, is administration of antibiotics, most frequently intravenous amoxicillin/clavulanic acid.\n\nLAHNC patients who are smoking and/or with malnutrition are at the highest risk of getting a pneumonia during or after radiotherapy. Because smoking is one of the risk factors of developing head and neck cancer chronic obstructive pulmonary disease (COPD) is frequently present in this group. Also, COPD is a known risk factor for developing pneumonias.\n\nAspiration is seen in all primary sites of head and neck cancer, sometimes it is seen more frequently in patients with cancer of the larynx and hypopharynx. No data of prophylactic administration of antibiotics are available in LAHNC patients. However, a Cochrane review was published to assess the effects of prophylactic antibiotic regimens for the prevention of respiratory tract infections(RTIs) and overall mortality in adults receiving intensive care.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with LAHNC which will be treated with CRT as discussed by a multidisciplinary team (i.e. a head and neck surgeon, a medical oncologist, and a radiation oncologist). This can be CRT as primary treatment or postoperative CRT.\n* Written informed consent\n* Expected adequacy of follow-up\n\nExclusion Criteria:\n\n* Patients with pneumonia within the last 14 days before start of CRT\n* Patients with other infections within the last 14 days within the last 14 days before start of CRT\n* Patients with use of maintenance antibiotics\n* Patients with antibiotic treatment within the last 14 days before start of CRT\n* Patients with an allergy on amoxicillin'}, 'identificationModule': {'nctId': 'NCT01598402', 'acronym': 'PANTAP', 'briefTitle': 'Efficacy of Prophylactic Treatment With Antibiotics During Concomitant Chemoradiotherapy in Patients With Head and Neck Cancer to Prevent Aspiration Pneumonia', 'organization': {'class': 'OTHER', 'fullName': 'Radboud University Medical Center'}, 'officialTitle': 'Efficacy and Cost Efficacy of Prophylactic Treatment With Antibiotics During Concomitant Chemoradiotherapy in Patients With Locally Advanced Head and Neck Cancer to Prevent Aspiration Pneumonia. A Randomized Phase II-III Study', 'orgStudyIdInfo': {'id': 'UMCNONCO201007'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'No prophylactic treatment', 'description': 'When a lower airway infection is suspected cultures will be taken and a chest radiography will be made; after that the standard care will be given (in most patients admission to hospital and start of intravenous antibiotics).'}, {'type': 'EXPERIMENTAL', 'label': 'prophylactic treatment', 'description': 'Administration of prophylactic amoxicillin/clavulanic acid suspension, 625 mg tid, start day 29 after the start of CRT until 14 days after the end of CRT. If a lower airway infection is suspected cultures will be taken and a chest radiography will be made; after that the standard care will be given (in most patients admission to hospital and start of intravenous antibiotics)', 'interventionNames': ['Drug: amoxicillin/clavulanic acid suspension']}], 'interventions': [{'name': 'amoxicillin/clavulanic acid suspension', 'type': 'DRUG', 'otherNames': ['The total duration of the use of amoxicillin /clavulanic acid suspension will be between 20 and 27 days.'], 'description': '625 mg tid, start day 29 after the start of CRT until 14 days after the end of CRT', 'armGroupLabels': ['prophylactic treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6800 TA', 'city': 'Arnhem', 'state': 'Gelderland', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'J. Blaisse, Md', 'role': 'CONTACT', 'email': 'jblaiss@alysis.nl', 'phone': '+31 26-3788888'}, {'name': 'S. Brouwer', 'role': 'CONTACT', 'email': 'sbrouwer@rijnstate.nl', 'phone': '+31 26-3788888'}, {'name': 'J. Blaisse, Md', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Ziekenhuis Rijnstate', 'geoPoint': {'lat': 51.98, 'lon': 5.91111}}, {'zip': '6525 GH', 'city': 'Nijmegen', 'state': 'Gelderland', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'C. van Herpen, Md', 'role': 'CONTACT', 'email': 'c.vanherpen@onco.umcn.nl', 'phone': '+31 24 361 03 53'}, {'name': 'C. Driessen, drs', 'role': 'CONTACT', 'email': 'c.driessen@onco.umcn.nl', 'phone': '+31 24 361 11 11', 'phoneExt': 'pager 3438'}, {'name': 'C.M.L van Herpen, Md, Phd', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'C. Driessen, drs', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'University Medical Center Nijmegen st Radboud', 'geoPoint': {'lat': 51.8425, 'lon': 5.85278}}, {'zip': '1815 JD', 'city': 'Alkmaar', 'status': 'NOT_YET_RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'C. Smorenburg, Md', 'role': 'CONTACT', 'email': 'c.h.smorenburg@mca.nl', 'phone': '+31 72-5484444'}, {'name': 'M. Komen', 'role': 'CONTACT', 'email': 'manon.komen@mca.nl', 'phone': '+31 72-5484444'}, {'name': 'C. Smorenburg, Md', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Medisch Centrum Alkmaar', 'geoPoint': {'lat': 52.63167, 'lon': 4.74861}}, {'zip': '9700 RB', 'city': 'Groningen', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'J. Gietema, Md', 'role': 'CONTACT', 'email': 'j.a.gietema@med.umcg.nl', 'phone': '+31 50 361 61 61'}, {'name': 'G. Sieling', 'role': 'CONTACT', 'email': 'g.c.m.sieling@umcg.nl', 'phone': '+31 50 361 61 61'}, {'name': 'J. Gietema, Md', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University Medical Centre Groningen', 'geoPoint': {'lat': 53.21917, 'lon': 6.56667}}, {'zip': '8934 AD', 'city': 'Leeuwarden', 'status': 'NOT_YET_RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'E. Fiets, Md', 'role': 'CONTACT', 'email': 'edward.fiets@znb.nl', 'phone': '+31 58-2866666'}, {'name': 'T. Rienks', 'role': 'CONTACT', 'email': 'tineke.rienks@znb.nl', 'phone': '+31 58-2866666'}, {'name': 'E. Fiets, Md', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Medisch centrum Leeuwarden', 'geoPoint': {'lat': 53.20271, 'lon': 5.80973}}, {'city': 'Maastricht', 'status': 'NOT_YET_RECRUITING', 'country': 'Netherlands', 'contacts': [{'role': 'CONTACT', 'email': 'ann.hoeben@mumc.nl'}, {'name': 'A. Hoeben, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Academical Hospital Maastricht (AZM)', 'geoPoint': {'lat': 50.84833, 'lon': 5.68889}}], 'centralContacts': [{'name': 'C. van Herpen, Md', 'role': 'CONTACT', 'email': 'c.vanherpen@onco.umcn.nl', 'phone': '+31 24 361 03 53'}, {'name': 'C. Driessen, drs', 'role': 'CONTACT', 'email': 'c.driessen@onco.umcn.nl', 'phone': '+31 24 361 11 11', 'phoneExt': '*pager: 3438'}], 'overallOfficials': [{'name': 'C. van Herpen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Medical Centre Nijmegen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Radboud University Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}