DAHANCA -21

DAHANCA21.jpg

Aims

This multicenter study aims at estimating the clinical effect of HBO on osteoradionecrosis.

Summary

114 patients with mandibular osteoradionecrosis (ORN) stage 2, 3 or 4 are randomised to:

  • Group 1
    • 30 preoperative and
    • 10 postoperative HBO sessions and
    • surgical intervention
  • Group 2
    • surgical intervention without HBO

Each HBO session implies inhalation of 100% oxygen during decompression to 14-15 meters for 90 minutes.

Primary endpoint is healing of bone exposure according to the CTCAE v 3.0 criteria, and is estimated one year after surgery.

Secondary endpoints are quality of life, pain intensity, antibiotics and pain medication, trismus, xerostomia and body mass index.

Following surgery, clinical evaluations are performed at:

  • baseline
  • 1 week
  • 1 and 3 months
  • 1 year

Copenhagen University Hospital is the main centre.

Aarhus, Odense, Liverpool (& other UK units), Gothenburg and Rome are participating centres.

The study is supported by Danish Cancer Association, Danish Cancer Research Foundation and Danish Dental Association.