Efficacy of Hyperbaric Oxygen Therapy in the Treatment of Osteoradionecrosis

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Osteoradionecrosis

Intervention / Treatment
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* Drug: hyperbaric oxygen


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Surgery<br>This is the standard arm. Surgery without hyperbaric oxygen treatment | |
| Experimental: Hyperbaric oxygen therapy with surgery<br>Intervention arm. Hyperbaric oxygen therapy with surgery. | Drug: hyperbaric oxygen<br>* 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<br>* Other names: ATC code V03AN012;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| absence of exposed bone, fistulae or ulceration. |  | 12 months after finishing therapy in the arm assigned to | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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osteoradionecrosis, mandible, radiotherapy, hyperbaric oxygen therapy