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

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 - PANTAP

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON39949

Enrollment

106

Registered

2011-05-24

Start date

2011-06-01

Completion date

Unknown

Last updated

2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

inhalation pneumonia

Interventions

Prophylactic treatment Amoxicillin/clavulanic acid suspension 625 mg tid start day 29 until 2 weeks after CRT

Eligibility

Age

18 Years to 99 Years

Inclusion 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

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

Design outcomes

Primary

Measure	Time frame
The primary outcome for the study will be the number of definite pneumonia and/ or suspected pneumonia.	—

Secondary

Measure	Time frame
-	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)