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

Phase 2

• Conditions: inhalation pneumonia; 10027656

• Registration Number: NL-OMON39949
• Lead Sponsor: niversitair Medisch Centrum Sint Radboud

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 106

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 day 29 of CRT
Patients with other infections within the last 14 days before day 29 of CRT
Patients with use of maintenance antibiotics
Patients with antibiotic treatment within the last 14 days before day 29 of CRT
Patients with an allergy on amoxicillin

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary outcome for the study will be the number of definite pneumonia and/<br /><br>or suspected pneumonia.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>-</p><br>