Efficacy of Hyperbaric Oxygen Therapy in the Treatment of Osteoradionecrosis

Radboud University Medical Center

Status and phase: Terminated; Phase 3; Phase 2

Conditions: Osteoradionecrosis

Treatments: Drug: hyperbaric oxygen

Study type: Interventional

Funder types: Other

Identifiers

NCT00989820

NL20963.091.08

Details and patient eligibility

About

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.

Full 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

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Surgery

No Intervention group

Description:

This is the standard arm. Surgery without hyperbaric oxygen treatment

Hyperbaric oxygen therapy with surgery

Experimental group

Description:

Intervention arm. Hyperbaric oxygen therapy with surgery.

Treatment:

Drug: hyperbaric oxygen