Head and Neck Cancer Clinical Trial
Official title:
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
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.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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