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
18 Years
N/A
Both
Head and Neck Cancer
Trial Information
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
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.
Inclusion Criteria:
- 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.
- Written informed consent
- Expected adequacy of follow-up
Exclusion Criteria:
- Patients with pneumonia within the last 14 days before start of CRT
- Patients with other infections within the last 14 days within the last 14 days before
start of CRT
- Patients with use of maintenance antibiotics
- Patients with antibiotic treatment within the last 14 days before start of CRT
- Patients with an allergy on amoxicillin
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
the number of definite pneumonia and/ or suspected pneumonia
Outcome Description:
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
Outcome Time Frame:
from day 1 of 1 CRT until 3,5 mnd after the last CRT
Safety Issue:
No
Principal Investigator
C. van Herpen, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
University Medical Centre Nijmegen
Authority:
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Study ID:
UMCNONCO201007
NCT ID:
NCT01598402
Start Date:
December 2011
Completion Date:
December 2014
Related Keywords:
- Head and Neck Cancer
- LAHNC
- Locally Advanced Head and Neck Cancer
- Head and Neck Neoplasms
- Pneumonia
- Pneumonia, Aspiration
Name | Location |
|---|
