NCT00989820

Efficacy of Hyperbaric Oxygen Therapy in the Treatment of Osteoradionecrosis

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

• Status: Terminated
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Radboud University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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

• Osteoradionecrosis

Interventions

Type	Name	Description
DRUG	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

Timeline

• Start date: 2009-10-01
• Primary completion: 2017-05-01
• Completion: 2020-03-01
• First posted: 2009-10-06
• Last updated: 2025-09-15

Locations

8 sites across 1 country: Netherlands