Efficacy of Hyperbaric Oxygen Therapy in the Treatment of Osteoradionecrosis

Phase 2

Terminated

• Conditions: Osteoradionecrosis
• Interventions: Drug: hyperbaric oxygen

• Registration Number: NCT00989820
• Lead Sponsor: Radboud University Medical Center

Brief Summary

The purpose of this study is to determine whether hyperbaric oxygen therapy is effective in the treatment of osteoradionecrosis (late complication of radiation therapy) of the jaw.

Detailed Description

Damage to the lower jaw as a late complication of radiation therapy (osteoradionecrosis (ORN)) is often seen in patients treated with radiation therapy for a tumor in the head and neck region. Part of the lower jaw becomes non-vital and has to be treated. ORN proofs to be a condition difficult to treat and the treatment for this condition varies.

In many countries hyperbaric oxygen therapy (HBOT) is added to the surgical treatment of ORN. Unfortunately there is no consensus whether the addition of hyperbaric oxygen therapy to the treatment of ORN is beneficial or not. This study has the aim to investigate the efficacy and cost-effectiveness of HBOT in the treatment of ORN.

Study Timeline

• Study Start: 2009-10-01
• Study First Submitted: 2009-10-05
• Study First Submitted QC: 2009-10-05
• Study First Posted: 2009-10-06
• Primary Completion: 2017-05-01
• Study Completion: 2020-03-01
• Status Verified: 2020-12
• Last Update Submitted: 2025-09-08
• Last Update Posted: 2025-09-15

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Informed consent

• Age ≥ 18 jr

• WHO performance status 0-2

• Last radiation treatment ≥ 6 month ago radiotherapy with curative intention and > 55 Gy. The affected part of the jaw must be in the target volume area of the radiotherapy field.

• Local recurrence must be ruled out

• Necrosis of the jaw with at least one of the following symptoms for over 3 month present:

  • Bone exposition which measures at least 1 cm
  • Evident bone lesions at radiologic evaluation (panorex) that fits the diagnosis ORN.
  • Non-healing extraction socket

Exclusion Criteria

• Former HBO treatment
• Contra indication for HBO treatment (pneumothorax)
• Bisphosphonate treatment in the medical history
• reirradiation in the medical history
• Osteosynthesis material in the affected area
• Distant metastasis
• Primary or recurrent tumor in the affected area
• Malignancies elsewhere

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hyperbaric oxygen therapy with surgery	hyperbaric oxygen	Intervention arm. Hyperbaric oxygen therapy with surgery.

Primary Outcome Measures

Name	Time	Method
absence of exposed bone, fistulae or ulceration.	12 months after finishing therapy in the arm assigned to	Number of patients with complete healing

Secondary Outcome Measures

Name	Time	Method
Pain score	one year after therapy in the arm assigned to.	VAS 0-10 (0 absence of pain, 10 unbearable pain)
Clinical and radiological assessment of the treatment response	one year after therapy in the arm assigned to.	Light photography and X-rays to assess the amount of patients without mucosal or bone lesions one year after therapy. The measurements between the start and finish of the inclusion are used to assess increase or decline of the lesions during therapy
Completion of the therapy in the arm for which patient has been randomized; if someone drops out of this study the reason will be scored.	one year after therapy in the arm assigned to.	Drop out rate of included patients and scoring of the reason for termination before completing the study.
Use of pain medication	one year after therapy in the arm assigned to.	type and quantity
Type of surgical intervention	one year after therapy in the arm assigned to.	For each individual patient the type of surgery is scored: sequestrectomy, marginal mandibula resection, segment resection
Quality of life	one year after therapy in the arm assigned to.	Quality of life questionnaires EORTC-QoL-C30, Head and Neck-C35. These QoL questionaires are for general QoL for oncology patients (C-30) with a specific part for head and neck oncology (C-35)
Cost effectiveness	one year after therapy in the arm assigned to.	Questionnaire EQ-5D

Trial Locations

Locations (8)

NKI/AvL; 🇳🇱 Amsterdam, Netherlands

VU University Medical centre; 🇳🇱 Amsterdam, Netherlands

University Medical Center Groningen; 🇳🇱 Groningen, Netherlands

Leiden University Medical Center; 🇳🇱 Leiden, Netherlands

Maastricht Universitary Medical Centre; 🇳🇱 Maastricht, Netherlands

Radboud University Nijmegen Medical Centre; 🇳🇱 Nijmegen, Netherlands

Erasmus University Medical Center; 🇳🇱 Rotterdam, Netherlands

University Medical Center Utrecht; 🇳🇱 Utrecht, Netherlands