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

• Status: Unknown status
• Trial end date: 2014-12-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Radboud University
• Treatments: Amoxicillin; Anti-Bacterial Agents; Antibiotics, Antitubercular; Clavulanic Acid; Clavulanic Acids

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