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Oxygen chamber therapy tested for jaw bone decay after cancer radiation

NCT ID NCT00989820

Disease control Sponsor: Radboud University Medical Center Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study looked at whether breathing pure oxygen in a pressure chamber (hyperbaric oxygen therapy) can help heal jaw damage caused by radiation treatment for cancer. The trial planned to include 20 people with jaw bone decay, but it was stopped early. The goal was to see if the therapy could close exposed bone and reduce pain.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
hyperbaric oxygen therapy
What this could lead to
If effective, this could offer a way to heal jaw damage caused by radiation therapy without major surgery.
What could go wrong
The trial was terminated early and only enrolled 20 people, so we don't have enough data to know if it works. Hyperbaric oxygen can cause ear pain or pressure injuries in rare cases.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

20 people

The number who actually took part.

Started

Oct 2009

Finished

Mar 2020

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

osteoradionecrosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Osteoradionecrosis

Contacts and locations

Locations

  • Erasmus University Medical Center

    Rotterdam, 3015CE, Netherlands

  • Leiden University Medical Center

    Leiden, 2333ZA, Netherlands

  • Maastricht Universitary Medical Centre

    Maastricht, 6229HX, Netherlands

  • NKI/AvL

    Amsterdam, 1066CX, Netherlands

  • Radboud University Nijmegen Medical Centre

    Nijmegen, 6525GA, Netherlands

  • University Medical Center Groningen

    Groningen, Netherlands

  • University Medical Center Utrecht

    Utrecht, 3584CX, Netherlands

  • VU University Medical centre

    Amsterdam, Netherlands

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