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

NCT01598402 | Unknown Phase 2

• 1 other identifier: UMCNONCO201007
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 6

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

Conditions

Head and Neck Cancer

Keywords

LAHNC; Locally Advanced Head and Neck Cancer

Outcome Measures

Primary Outcomes (1)

• the number of definite pneumonia and/ or suspected pneumonia

  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

  from day 1 of 1 CRT until 3,5 mnd after the last CRT

Secondary Outcomes (8)

• effects on Quality of Life

  Baseline, Day 28 last day of CRT, 3,5 months after CRT

• Number and kind of positive blood cultures

  from day 1 of 1 CRT until 3,5 mnd after the last CRT

• number of admissions to hospital

  from day 1 of 1 CRT until 3,5 mnd after the last CRT

• Number of days of admission

  from day 1 of 1 CRT until 3,5 mnd after the last CRT

• Effects on mortality

  from day 1 of 1 CRT until 3,5 mnd after the last CRT

Study Arms (2)

No prophylactic treatment

NO INTERVENTION

When a lower airway infection is suspected cultures will be taken and a chest radiography will be made; after that the standard care will be given (in most patients admission to hospital and start of intravenous antibiotics).

prophylactic treatment

EXPERIMENTAL

Administration of prophylactic amoxicillin/clavulanic acid suspension, 625 mg tid, start day 29 after the start of CRT until 14 days after the end of CRT. If a lower airway infection is suspected cultures will be taken and a chest radiography will be made; after that the standard care will be given (in most patients admission to hospital and start of intravenous antibiotics)

Drug: amoxicillin/clavulanic acid suspension

Interventions

amoxicillin/clavulanic acid suspension DRUG

625 mg tid, start day 29 after the start of CRT until 14 days after the end of CRT

Also known as: The total duration of the use of amoxicillin /clavulanic acid suspension will be between 20 and 27 days.

prophylactic treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Radboud University Medical Center: lead

Study Sites (6)

Ziekenhuis Rijnstate

Arnhem, Gelderland, 6800 TA, Netherlands

RECRUITING

University Medical Center Nijmegen st Radboud

Nijmegen, Gelderland, 6525 GH, Netherlands

RECRUITING

Medisch Centrum Alkmaar

Alkmaar, 1815 JD, Netherlands

NOT YET RECRUITING

University Medical Centre Groningen

Groningen, 9700 RB, Netherlands

RECRUITING

Medisch centrum Leeuwarden

Leeuwarden, 8934 AD, Netherlands

NOT YET RECRUITING

Academical Hospital Maastricht (AZM)

Maastricht, Netherlands

NOT YET RECRUITING

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

Amoxicillin

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Organic Chemicals; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• C. van Herpen, MD

  University Medical Centre Nijmegen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

C. van Herpen, Md

CONTACT

+31 24 361 03 53; c.vanherpen@onco.umcn.nl

C. Driessen, drs

CONTACT

+31 24 361 11 11; c.driessen@onco.umcn.nl

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2012
• First Posted: May 15, 2012
• Study Start: December 1, 2011
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2014
• Last Updated: July 15, 2013

Record last verified: 2013-07

Locations

NL (6)