A Phase 2/3 interventional study of hyperbaric oxygen in Osteoradionecrosis, sponsored by Radboud University Medical Center. Terminated at 8 sites in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-15.
Sponsored by Radboud University Medical Center · Phase 2/3, Interventional, and Treatment
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.
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.
24 studies on the registry are indexed under Osteoradionecrosis; 8 are open to participants now.
This study's enrollment of 20 is below the median of 60 across 13 interventional studies indexed under Osteoradionecrosis.
Browse Osteoradionecrosis studies →Radboud University Medical Center is the lead sponsor of 986 studies on the registry; 136 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Necrosis of the jaw with at least one of the following symptoms for over 3 month present:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
This is the standard arm. Surgery without hyperbaric oxygen treatment
Intervention arm. Hyperbaric oxygen therapy with surgery.
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
Also known as: Linde Gas Therapeutics Benelux B.V., RVG 30355, ATC code V03AN012
absence of exposed bone, fistulae or ulceration.
Number of patients with complete healing
Time frame: 12 months after finishing therapy in the arm assigned to
Pain score
VAS 0-10 (0 absence of pain, 10 unbearable pain)
Time frame: one year after therapy in the arm assigned to.
Clinical and radiological assessment of the treatment response
Light photography and X-rays to assess the amount of patients without mucosal or bone lesions one year after therapy. The measurements between the start and finish of the inclusion are used to assess increase or decline of the lesions during therapy
Time frame: one year after therapy in the arm assigned to.
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.
Drop out rate of included patients and scoring of the reason for termination before completing the study.
Time frame: one year after therapy in the arm assigned to.
Use of pain medication
type and quantity
Time frame: one year after therapy in the arm assigned to.
Type of surgical intervention
For each individual patient the type of surgery is scored: sequestrectomy, marginal mandibula resection, segment resection
Time frame: one year after therapy in the arm assigned to.
Quality of life
Quality of life questionnaires EORTC-QoL-C30, Head and Neck-C35. These QoL questionaires are for general QoL for oncology patients (C-30) with a specific part for head and neck oncology (C-35)
Time frame: one year after therapy in the arm assigned to.
Cost effectiveness
Questionnaire EQ-5D
Time frame: one year after therapy in the arm assigned to.
Ran from Oct 2009 to primary completion in May 2017, 91 months.
How these figures are worked out, and which studies are left out of them.
This study is terminated, as verified in Dec 2020. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Hyperbaric Oxygen
Radboud University Medical Center →