Efficacy of Hyperbaric Oxygen Therapy in the Treatment of Osteoradionecrosis

• Status: Terminated
• Trial end date: 2018-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Radboud University
• Treatments: Coal Tar

Criteria

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