期刊
RADIOTHERAPY AND ONCOLOGY
卷 166, 期 -, 页码 137-144出版社
ELSEVIER IRELAND LTD
DOI: 10.1016/j.radonc.2021.11.021
关键词
Osteoradionecrosis; Hyperbaric oxygen treatment; Randomised clinical trial; Radiation therapy; Head and neck cancer; Mandible
资金
- Danish Cancer Society
- National Institute for Health Research (NIHR) infrastructure at Leeds
- Danish Cancer Research foundation
- Danish Dental Association, Doctor Sofus Carl Emil and Wife Olga Doris Friis
- Wallenius Foundation
- TUA research founding
- 'Cancer Research UK'
- 'UK National Cancer Research Institute'
This study investigated the effect of hyperbaric oxygen treatment on osteoradionecrosis (ORN) of the mandible through two randomized controlled multicentre trials. The results showed that hyperbaric oxygen did not significantly improve the healing outcome of ORN after surgical removal of necrotic bone. However, it was associated with improved xerostomia, salivary flow rate, and dysphagia.
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. (C) 2021 The Authors. Published by Elsevier B.V.
作者
我是这篇论文的作者
点击您的名字以认领此论文并将其添加到您的个人资料中。
推荐
暂无数据