TerminatedPhase 2/3

Efficacy of Hyperbaric Oxygen Therapy in the Treatment of Osteoradionecrosis

Stopped: Recruitment problems, patients refused to participate

Netherlands20 participantsStarted 2009-10

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

absence of exposed bone, fistulae or ulceration.

Timeframe: 12 months after finishing therapy in the arm assigned to

Trial details

NCT IDNCT00989820

SponsorRadboud University Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2017-05-01

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