Efficacy of Hyperbaric Oxygen Therapy in the Treatment of Osteoradionecrosis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2020-03-01

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 complication of radiation therapy) of the jaw.

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Detailed Description

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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.

Conditions

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Osteoradionecrosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Surgery

This is the standard arm. Surgery without hyperbaric oxygen treatment

Group Type NO_INTERVENTION

No interventions assigned to this group

Hyperbaric oxygen therapy with surgery

Intervention arm. Hyperbaric oxygen therapy with surgery.

Group Type EXPERIMENTAL

hyperbaric oxygen

Intervention Type DRUG

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

Interventions

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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

Intervention Type DRUG

Other Intervention Names

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Linde Gas Therapeutics Benelux B.V. RVG 30355 ATC code V03AN012

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No