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. The 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
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). Around half of the patients will develop an aspiration pneumonia during or shortly after the treatment. Patients, 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. The 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. LAHNC 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. Aspiration 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
106
625 mg tid, start day 29 after the start of CRT until 14 days after the end of CRT
Ziekenhuis Rijnstate
Arnhem, Gelderland, Netherlands
RECRUITINGUniversity Medical Center Nijmegen st Radboud
Nijmegen, Gelderland, Netherlands
RECRUITINGMedisch Centrum Alkmaar
Alkmaar, Netherlands
NOT_YET_RECRUITINGUniversity Medical Centre Groningen
Groningen, Netherlands
RECRUITINGMedisch centrum Leeuwarden
Leeuwarden, Netherlands
NOT_YET_RECRUITINGAcademical Hospital Maastricht (AZM)
Maastricht, Netherlands
NOT_YET_RECRUITINGthe number of definite pneumonia and/ or suspected pneumonia
Definite pneumonia: Evidence of pneumonia on chest radiography or 3 or more of the following: Sustained fever (temperature\> 100 f \[38°C\]), Rales or rhonchi on chest auscultation Sputum Gram stain showing substantial leukocytes Sputum culture showing a respiratory pathogen Suspected pneumonia: At least 2 of the 4 following features are present, without evidence of pneumonia on chest radiography: Sustained fever (temperature\> 100 f \[38°C\]) Rales or rhonchi on chest auscultation Sputum Gram stain showing substantial leukocytes Sputum culture showing a respiratory pathogen
Time frame: from day 1 of 1 CRT until 3,5 mnd after the last CRT
effects on Quality of Life
to investigate the effects on QoL after prophylactic treatment with antibiotics Patients fill in the following questionnaires: QLQ-C30, EORTC H\&N35, PSHHN, EQ-5D and the VAS, SF-36
Time frame: Baseline, Day 28 last day of CRT, 3,5 months after CRT
Number and kind of positive blood cultures
Time frame: from day 1 of 1 CRT until 3,5 mnd after the last CRT
number of admissions to hospital
Time frame: from day 1 of 1 CRT until 3,5 mnd after the last CRT
Number of days of admission
Time frame: from day 1 of 1 CRT until 3,5 mnd after the last CRT
Effects on mortality
Mortality due to definite and/or suspected pneumonia
Time frame: from day 1 of 1 CRT until 3,5 mnd after the last CRT
effects on mucositis: grade and duration
Mucositis grade according to CTCAE v.4.0 and duration
Time frame: from day 1 of 1 CRT until 3,5 mnd after the last CRT
side effects of amoxicillin/clavulanic acid
side effects of amoxicillin/clavulanic acid
Time frame: from day 1 of 1 CRT until 3,5 mnd after the last CRT
Effects on numbers and causative agents of infections at other sites
numbers and causative agents of infections at other sites during follow up (3.5 months after the end of CRT)
Time frame: during follow up
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