study of the effectiveness and cost effectiveness of giving prophylactic antibiotics to patients with locally advanced head and neck cancertreated with chemo-radiotherapy

• Conditions: Patients with LAHNC which will be treated with chemoradiotherapy, as primary treatment or as postoperative treatment; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2011-000076-33-NL
• Lead Sponsor: niversity Medical Centre Nijmegen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-05-25
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To observe a decrease in number of definite and/or suspected pneumonia after prophylactic treatment with antibiotics during CRT in patients with LAHNC;Secondary Objective: To observe a decrease in the number of admissions in the hospital <br>To observe a decrease in the number of days of admission in the hospital <br>To measure Quality of life (QoL) <br>To investigate the effects on mortality <br>To observe side effects of amoxicillin clavulanic acid <br>To observe causative agents, including amoxicillin-clavulanic acid resistant, of infections at other sites during follow-up (3.5 months after the end of CRT);Primary end point(s): the number of definite pneumonia and/ or suspected pneumonia.;Timepoint(s) of evaluation of this end point: every patient visit during the trial en follow up period

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): QoL: measured with the EORTC Quality of Life Quistionnaire C30 (QLQ-C30), the EORTC QLQ Head and Neck Cancer-Specific Module (EORTC H&N35), the PSHHN, the EuroQol-5D(EQ-5D), the EQ- 5D VAS and the SF-36 <br>Number and kind of positive blood cultures <br>Number of admissions to hospital <br>Number of days of admission <br>Mortality due to definite and/or suspected pneumonia <br>Mucositis grade according to CTCAE v.4.0 and duration <br>Side effects of amoxicillin/clavulanic acid <br>Numbers and causative agents of infections at other sites during follow up (3.5 months after the end of CRT) including amoxicillin-clavulanic acid resistant strains;Timepoint(s) of evaluation of this end point: lpo: after duration of this trail inc. 1 year follow up: