Clinical Trial: Efficacy of Prophylactic Treatment With Antibiotics During Concomitant Chemoradiotherapy in Patients With Head and Neck Cancer to Prevent Aspiration Pneumonia

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

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 Aspir

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 Summary:

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
Sponsor: Radboud University

Current Primary Outcome: the number of definite pneumonia and/ or suspected pneumonia [ Time Frame: from day 1 of 1 CRT until 3,5 mnd after the last CRT ]

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



Original Primary Outcome: Same as current

Current Secondary Outcome:

  • effects on Quality of Life [ Time Frame: Baseline, Day 28 last day of CRT, 3,5 months after CRT ]

    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

  • 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 [ Time Frame: from day 1 of 1 CRT until 3,5 mnd after the last CRT ]
    Mortality due to definite and/or suspected pneumonia
  • effects on mucositis: grade and duration [ Time Frame: from day 1 of 1 CRT until 3,5 mnd after the last CRT ]
    Mucositis grade according to CTCAE v.4.0 and duration
  • side effects of amoxicillin/clavulanic acid [ Time Frame: from day 1 of 1 CRT until 3,5 mnd after the last CRT ]
    side effects of amoxicillin/clavulanic acid
  • Effects on numbers and causative agents of infections at other sites [ Time Frame: during follow up ]
    numbers and causative agents of infections at other sites during follow up (3.5 months after the end of CRT)


Original Secondary Outcome: Same as current

Information By: Radboud University

Dates:
Date Received: February 2, 2012
Date Started: December 2011
Date Completion: December 2014
Last Updated: July 12, 2013
Last Verified: July 2013