Efficacy of Hyperbaric Oxygen Therapy in the Treatment of Osteoradionecrosis

Efficacy of Adding Hyperbaric Oxygen Therapy to the Treatment of Late Radiation Damage of the Lower Jaw (Osteoradionecrosis).

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.

Study Overview

• Status: Terminated
• Conditions: Osteoradionecrosis
• Intervention / Treatment: Drug: hyperbaric oxygen

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 Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Netherlands
  • Amsterdam, Netherlands, 1066CX
    • NKI/AvL
  • Amsterdam, Netherlands
    • VU University Medical Centre
  • Groningen, Netherlands
    • University Medical Center Groningen
  • Leiden, Netherlands, 2333ZA
    • Leiden University Medical Center
  • Maastricht, Netherlands, 6229HX
    • Maastricht Universitary Medical Centre
  • Nijmegen, Netherlands, 6525GA
    • Radboud University Nijmegen Medical Centre
  • Rotterdam, Netherlands, 3015CE
    • Erasmus University Medical Center
  • Utrecht, Netherlands, 3584CX
    • University Medical Center Utrecht

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Surgery; This is the standard arm. Surgery without hyperbaric oxygen treatment
Experimental: Hyperbaric oxygen therapy with surgery; Intervention arm. Hyperbaric oxygen therapy with surgery.	Drug: hyperbaric oxygen; 30 session inhalation of 100% oxygen in a pressure chamber under 2.4 ATA for 90 minutes a day before surgery and 10 session hyperbaric oxygen therapy (as mentioned before) after surgery; Other Names: Linde Gas Therapeutics Benelux B.V.; RVG 30355; ATC code V03AN012

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain score	VAS 0-10 (0 absence of pain, 10 unbearable pain)	one year after therapy in the arm assigned to.
Clinical and radiological assessment of the treatment response	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	one year after therapy in the arm assigned to.
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.	Drop out rate of included patients and scoring of the reason for termination before completing the study.	one year after therapy in the arm assigned to.
Use of pain medication	type and quantity	one year after therapy in the arm assigned to.
Type of surgical intervention	For each individual patient the type of surgery is scored: sequestrectomy, marginal mandibula resection, segment resection	one year after therapy in the arm assigned to.
Quality of life	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)	one year after therapy in the arm assigned to.
Cost effectiveness	Questionnaire EQ-5D	one year after therapy in the arm assigned to.

Collaborators and Investigators

• Sponsor: Radboud University Medical Center
• Investigators: Principal Investigator: Francois Dieleman, MD DMD, Radboud University Medical Center; Study Director: Thijs Merkx, MD DMD PhD, Radboud University Medical Center; Study Director: Hans Kaanders, MD PhD, Raboud University Medical Centre

Publications and helpful links

Helpful Links

• Dutch Co-operative Head and Neck Group

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2009
• Primary Completion (Actual): May 1, 2017
• Study Completion (Actual): March 1, 2020

Study Registration Dates

• First Submitted: October 5, 2009
• First Submitted That Met QC Criteria: October 5, 2009
• First Posted (Estimated): October 6, 2009

Study Record Updates

• Last Update Posted (Estimated): September 15, 2025
• Last Update Submitted That Met QC Criteria: September 8, 2025
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: radiotherapy; hyperbaric oxygen therapy; mandible; osteoradionecrosis
• Additional Relevant MeSH Terms: Wounds and Injuries; Radiation Injuries; Osteoradionecrosis; Therapeutics; Respiratory Therapy; Oxygen Inhalation Therapy; Hyperbaric Oxygenation
• Other Study ID Numbers: NL20963.091.08