This trial is active, not recruiting.

Condition osteoradionecrosis
Treatment hyperbaric oxygen
Phase phase 2/phase 3
Sponsor Radboud University
Start date October 2009
End date October 2016
Trial size 20 participants
Trial identifier NCT00989820, NL20963.091.08


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
(No Intervention)
This is the standard arm. Surgery without hyperbaric oxygen treatment
Intervention arm. Hyperbaric oxygen therapy with surgery.
hyperbaric oxygen Linde Gas Therapeutics Benelux B.V.
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

Primary Outcomes

absence of exposed bone, fistulae or ulceration.
time frame: 12 months after finishing therapy in the arm assigned to

Secondary Outcomes

Pain score
time frame: one year after primairy therapy assigned to.
Clinical and radiological assessment of the treatment response
time frame: 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.
time frame: one year after initial therapy
Use of pain medication
time frame: one year after initial therapy
Type of surgical intervention (sequestrectomy, marginal mandibula resection, segment resection)
time frame: one year after initial therapy
Quality of life
time frame: one year after initial therapy
Cost effectiveness
time frame: one year after initial therapy

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Efficacy of Adding Hyperbaric Oxygen Therapy to the Treatment of Late Radiation Damage of the Lower Jaw (Osteoradionecrosis).
Principal investigator Francois Dieleman, MD DMD
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
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by Radboud University.