Clinical trial NCT01598402: Efficacy of Prophylactic Treatment With Antibiotics During Concomitant Chemoradiotherapy in Patients With Head and Neck Cancer to Prevent Aspiration Pneumonia
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Head and Neck Cancer
Keywords: LAHNC
Locally Advanced Head and Neck Cancer
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
First posted: 2012-05-15
Enrollment: 106
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
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
Secondary outcomes:
measure: effects on Quality of Life
timeFrame: Baseline, Day 28 last day of CRT, 3,5 months after CRT
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
measure: effects on mucositis: grade and duration
timeFrame: from day 1 of 1 CRT until 3,5 mnd after the last CRT
measure: side effects of amoxicillin/clavulanic acid
timeFrame: from day 1 of 1 CRT until 3,5 mnd after the last CRT
measure: Effects on numbers and causative agents of infections at other sites
timeFrame: during follow up
Other outcomes:
Locations:
city: Arnhem
country: Netherlands
facility: Ziekenhuis Rijnstate
state: Gelderland
city: Nijmegen
country: Netherlands
facility: University Medical Center Nijmegen st Radboud
state: Gelderland
city: Alkmaar
country: Netherlands
facility: Medisch Centrum Alkmaar
city: Groningen
country: Netherlands
facility: University Medical Centre Groningen
city: Leeuwarden
country: Netherlands
facility: Medisch centrum Leeuwarden
city: Maastricht
country: Netherlands
facility: Academical Hospital Maastricht (AZM)
Study officials:
affiliation: University Medical Centre Nijmegen
name: C. van Herpen, MD
role: PRINCIPAL_INVESTIGATOR
References: