TY - JOUR
T1 - Hyperbaric oxygen treatment of mandibular osteoradionecrosis
T2 - Combined data from the two randomized clinical trials DAHANCA-21 and NWHHT2009-1
AU - Forner, Lone E.
AU - Dieleman, François J.
AU - Shaw, Richard J.
AU - Kanatas, Anastasios
AU - Butterworth, Chris J.
AU - Kjeller, G. ran
AU - Alsner, Jan
AU - Overgaard, Jens
AU - Hillerup, S. ren
AU - Hyldegaard, Ole
AU - Arnell, Per
AU - von Buchwald, Christian
AU - Kaanders, Johannes H. A. M.
AU - Smeele, Ludi E.
AU - Specht, Lena
AU - Johansen, J. rgen
AU - Witjes, Max J. H.
AU - Merkx, Matthias A. W.
AU - Jansen, Erik C.
N1 - Funding Information: Research funding support from ‘ Cancer Research UK ’ who supported the work done in Liverpool Trials unit in coordinating UK data. Funding Information: This research was supported by the Danish Cancer Society, the National Institute for Health Research (NIHR) infrastructure at Leeds (DenTCRU|), Danish Cancer Research foundation, Danish Dental Association, Doctor Sofus Carl Emil and Wife Olga Doris Friiś Foundation, The Wallenius Foundation and TUA research founding. We wish to thank clinical trial coordinators Binyam Tesfaye and Matthew Bickerstaff and staff members of the Hyperbaric Units Martin Forchhammer, Annet Schack von Brockdorff, Paul Banks, Gillian Dukanovic, Joakim Trogen and Kerstin Olausson for their help. Funding Information: This research was supported by the Danish Cancer Society, the National Institute for Health Research (NIHR) infrastructure at Leeds (DenTCRU|), Danish Cancer Research foundation, Danish Dental Association, Doctor Sofus Carl Emil and Wife Olga Doris Friis? Foundation, The Wallenius Foundation and TUA research founding. We wish to thank clinical trial coordinators Binyam Tesfaye and Matthew Bickerstaff and staff members of the Hyperbaric Units Martin Forchhammer, Annet Schack von Brockdorff, Paul Banks, Gillian Dukanovic, Joakim Trogen and Kerstin Olausson for their help. Research funding support from ?Cancer Research UK? who supported the work done in Liverpool Trials unit in coordinating UK data. The contribution of the ?UK National Cancer Research Institute? who adopted the trial to support UK recruitment. The views expressed are those of the authors and not those of any funders or national health institutions. Publisher Copyright: © 2021 The Authors
PY - 2022/1/1
Y1 - 2022/1/1
N2 - 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.
AB - 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.
KW - Head and neck cancer
KW - Hyperbaric oxygen treatment
KW - Mandible
KW - Osteoradionecrosis
KW - Radiation therapy
KW - Randomised clinical trial
UR - http://www.scopus.com/inward/record.url?scp=85120882971&partnerID=8YFLogxK
U2 - https://doi.org/10.1016/j.radonc.2021.11.021
DO - https://doi.org/10.1016/j.radonc.2021.11.021
M3 - Article
C2 - 34843843
SN - 0167-8140
VL - 166
SP - 137
EP - 144
JO - Radiotherapy and oncology
JF - Radiotherapy and oncology
ER -