OsteoradionecrosisPhase 2/3NCT00989820
Efficacy of Hyperbaric Oxygen Therapy in the Treatment of Osteoradionecrosis
A Phase 2/3 study testing hyperbaric oxygen in people with Osteoradionecrosis, run by Radboud University Medical Center at 8 sites in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoradionecrosis
- What is being tested?
- hyperbaric oxygen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 8 sitesNetherlands
- Study dates
- Oct 2009to 1 Mar 2020
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
Show all 9Show fewer
- Bone exposition which measures at least 1 cm
- Evident bone lesions at radiologic evaluation (panorex) that fits the diagnosis ORN.
- Non-healing extraction socket
Who cannot join
- 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 locations and contacts
8 sites in 1 country.
8 sites in 1 country
Netherlands8 sites
NKI/AvL
Amsterdam, 1066CX
VU University Medical centre
Amsterdam
University Medical Center Groningen
Groningen
Leiden University Medical Center
Leiden, 2333ZA
Maastricht Universitary Medical Centre
Maastricht, 6229HX
Radboud University Nijmegen Medical Centre
Nijmegen, 6525GA
Erasmus University Medical Center
Rotterdam, 3015CE
University Medical Center Utrecht
Utrecht, 3584CX
About this study
Official title: Efficacy of Adding Hyperbaric Oxygen Therapy to the Treatment of Late Radiation Damage of the Lower Jaw (Osteoradionecrosis).
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.
Read the 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
- Being tested
- hyperbaric oxygen
- Keywords
- osteoradionecrosis, mandible, radiotherapy, hyperbaric oxygen therapy
- Medical subject headings
- Osteoradionecrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hyperbaric oxygenDrug
Also called Linde Gas Therapeutics Benelux B.V., RVG 30355, ATC code V03AN012
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
| Study group | Role | What they receive |
|---|---|---|
| Surgery | No intervention | This is the standard arm. Surgery without hyperbaric oxygen treatment |
| Hyperbaric oxygen therapy with surgery | Experimental | Intervention arm. Hyperbaric oxygen therapy with surgery. Receives: Drug: hyperbaric oxygen |
What is being measured
The primary outcome is the main question the study is designed to answer.
absence of exposed bone, fistulae or ulceration.
Number of patients with complete healing
Measured: 12 months after finishing therapy in the arm assigned to
Secondary outcomes (7)
Pain score
VAS 0-10 (0 absence of pain, 10 unbearable pain)
Measured: 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
Measured: 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.
Measured: one year after therapy in the arm assigned to.
Use of pain medication
type and quantity
Measured: 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
Measured: 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)
Measured: one year after therapy in the arm assigned to.
Cost effectiveness
Questionnaire EQ-5D
Measured: one year after therapy in the arm assigned to.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2009 (estimated)
- Study startOct 2009
- Primary completion1 May 2017
- Study completion1 Mar 2020
Why it stopped: Recruitment problems, patients refused to participate
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoradionecrosisStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Francois Dieleman, MD DMD, Principal investigator, Radboud University Medical CenterThijs Merkx, MD DMD PhD, Study director, Radboud University Medical CenterHans Kaanders, MD PhD, Study director, Raboud University Medical Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00989820
- Sponsor's protocol ID
- NL20963.091.08
- Status last verified
- Dec 2020
- First submitted
- 5 Oct 2009
- Last updated
- 15 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Adding Hyperbaric Oxygen Therapy to the Treatment of Late Radiation Damage of the Lower Jaw (Osteoradionecrosis).
- ClinicalTrials.gov ID
- NCT00989820
- Acronym / sponsor ID
- NL20963.091.08
- Conditions
- Osteoradionecrosis
- Keywords
- osteoradionecrosis, mandible, radiotherapy, hyperbaric oxygen therapy
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment problems, patients refused to participate
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- Oct 2009 (actual)
- Primary completion
- 1 May 2017 (actual)
- Study completion
- 1 Mar 2020 (actual)
- First posted
- 6 Oct 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surgery | No intervention | –This is the standard arm. Surgery without hyperbaric oxygen treatment |
| Hyperbaric oxygen therapy with surgery | Experimental | Drug: hyperbaric oxygenIntervention arm. Hyperbaric oxygen therapy with surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| hyperbaric oxygenAlso: Linde Gas Therapeutics Benelux B.V., RVG 30355, ATC code V03AN01230 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 | Drug | Hyperbaric oxygen therapy with surgery |
Primary outcome
absence of exposed bone, fistulae or ulceration.
Time frame: 12 months after finishing therapy in the arm assigned to
Number of patients with complete healing
7 secondary outcomes
Pain score
Time frame: one year after therapy in the arm assigned to.
Clinical and radiological assessment of the treatment response
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.
Time frame: one year after therapy in the arm assigned to.
Use of pain medication
Time frame: one year after therapy in the arm assigned to.
Type of surgical intervention
Time frame: one year after therapy in the arm assigned to.
Quality of life
Time frame: one year after therapy in the arm assigned to.
Cost effectiveness
Time frame: one year after therapy in the arm assigned to.
Results and safety
The study was stopped early (reason given: Recruitment problems, patients refused to participate). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2025.
- Dutch Co-operative Head and Neck GroupLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Francois Dieleman, MD DMD principal investigator
Radboud University Medical Center
Thijs Merkx, MD DMD PhD study director
Radboud University Medical Center
Hans Kaanders, MD PhD study director
Raboud University Medical Centre
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing hyperbaric oxygen in people with Osteoradionecrosis, run by Radboud University Medical Center at 8 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 15 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Recruitment problems, patients refused to participate). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
absence of exposed bone, fistulae or ulceration. (time frame: 12 months after finishing therapy in the arm assigned to). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2025.