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Randomized Controlled Trial
. 2022 Jan:166:137-144.
doi: 10.1016/j.radonc.2021.11.021. Epub 2021 Nov 26.

Hyperbaric oxygen treatment of mandibular osteoradionecrosis: Combined data from the two randomized clinical trials DAHANCA-21 and NWHHT2009-1

Lone E Forner  1 , François J Dieleman  2 , Richard J Shaw  3 , Anastasios Kanatas  4 , Chris J Butterworth  5 , Göran Kjeller  6 , Jan Alsner  7 , Jens Overgaard  7 , Søren Hillerup  8 , Ole Hyldegaard  9 , Per Arnell  10 , Christian von Buchwald  11 , Johannes H A M Kaanders  12 , Ludi E Smeele  13 , Lena Specht  14 , Jørgen Johansen  15 , Max J H Witjes  16 , Matthias A W Merkx  17 , Erik C Jansen  9
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Free article
Randomized Controlled Trial

Hyperbaric oxygen treatment of mandibular osteoradionecrosis: Combined data from the two randomized clinical trials DAHANCA-21 and NWHHT2009-1

Lone E Forner et al. Radiother Oncol. 2022 Jan.
Free article

Abstract

Purpose: Osteoradionecrosis (ORN) of the mandible is a serious complication of head and neck radiotherapy. This study aims to investigate the effect of hyperbaric oxygen (HBO) treatment on ORN in two randomized, controlled multicentre trials.

Methods and materials: Patients with ORN with indication for surgical treatment were randomised to either group 1: surgical removal of necrotic mandibular bone supplemented by 30 pre- and 10 postoperative HBO exposures at 243 kPa for 90 min each, or group 2: surgical removal of necrotic bone only. Primary outcome was healing of ORN one year after surgery evaluated by a clinically adjusted version of the Common Toxicity Criteria of Adverse Events (CTCAE) v 3.0. Secondary outcomes included xerostomia, unstimulated and stimulated whole salivation rates, trismus, dysphagia, pain, Activities of Daily Living (ADL) and quality of life according to EORTC. Data were combined from two separate trials. Ninety-seven were enrolled and 65 were eligible for the intent-to-treat analysis. The 33% drop-out was equally distributed between groups.

Results: In group 1, 70% (21/30) healed compared to 51% (18/35) in group 2. HBO was associated with an increased chance of healing independent of baseline ORN grade or smoking status as well as improved xerostomia, unstimulated whole salivary flow rate, and dysphagia. Due to insufficient recruitment, none of the endpoints reached a statistically significant difference between groups. ADL data could only be obtained from 50 patients.

Conclusion: Hyperbaric oxygen did not significantly improve the healing outcome of osteoradionecrosis after surgical removal of necrotic bone as compared to standard care (70% vs. 51%). This effect is not statistically significant due to the fact that the study was underpowered and is therefore prone to type II error.

Keywords: Head and neck cancer; Hyperbaric oxygen treatment; Mandible; Osteoradionecrosis; Radiation therapy; Randomised clinical trial.

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