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 damage after radiotherapy) of the jaw.

Detailed Description

Late radiation damage to the lower jaw (osteoradionecrosis (ORN)) is often seen in patients treated with radiotherapy 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
• Study First Submitted: 2009-10-05
• Study First Submitted QC: 2009-10-05
• Study First Posted: 2009-10-06
• Status Verified: 2016-04
• Primary Completion: 2017-05-01
• Last Update Submitted: 2017-05-29
• Last Update Posted: 2017-05-31
• Study Completion: 2018-05-01

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

Secondary Outcome Measures

Name	Time	Method
Clinical and radiological assessment of the treatment response	one year after initial therapy
Pain score	one year after primairy therapy assigned to.
Use of pain medication	one year after initial therapy
Type of surgical intervention (sequestrectomy, marginal mandibula resection, segment resection)	one year after initial 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 initial therapy
Quality of life	one year after initial therapy
Cost effectiveness	one year after initial therapy

Trial Locations

Locations (8)

NKI/AvL; 🇳🇱 Amsterdam, Netherlands

VU University Medical centre; 🇳🇱 Amsterdam, Netherlands

University Medical Center Groningen; 🇳🇱 Groningen, Netherlands

Radboud University Nijmegen Medical Centre; 🇳🇱 Nijmegen, Netherlands

Maastricht Universitary Medical Centre; 🇳🇱 Maastricht, Netherlands

Erasmus University Medical Center; 🇳🇱 Rotterdam, Netherlands

Leiden University Medical Center; 🇳🇱 Leiden, Netherlands

University Medical Center Utrecht; 🇳🇱 Utrecht, Netherlands