Hyperbaric Oxygen to Prevent Osteoradionecrosis of the Irradiated Mandible (HOPON) - HOPO

The University of Liverpool0 sites144 target enrollmentMarch 26, 2008

Overview

No summary available.

Registry

who.int

Start Date

March 26, 2008

End Date

January 24, 2018

Last Updated

7 years ago

Study Type

Interventional clinical trial of medicinal product

Sponsor

The University of Liverpool

•1\.Age \> 18 years
•2\.Prior history of external beam radiotherapy (dose \> 50Gy) to mandible or prior history of brachytherapy with equivalent radiation dose as above.
•3\.No evidence of cancer recurrence
•4\.New diagnosis of condition requiring surgery to mandible (commonest examples but not limited to: dental extraction, implant placement, surgical tooth, cyst or osteosynthesis plate removal)
•5\.Patient has read and understood information leaflet and is willing to be randomised.
•6\.Patient competent to consent and psychologically / physically fit for HBO.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1\.2 Adults (18\-64 years) yes
•F.1\.2\.1 Number of subjects for this age range 221

•1\.Known contraindications to HBO:
•a.Lung disease: Chronic obstructive airways disease; bullous lung disease, acute or chronic pulmonary infection; uncontrolled asthma, untreated pneumothorax
•b.Middle ear disease; previous middle ear operations, eustachian tube dysfunction or recurrent attacks of vertigo
•2\.Prior hyperbaric oxygen therapy
•3\.Prior diagnosis of osteoradionecrosis of the mandible
•4\.Previous surgery for osteoradionecrosis
•5\.Any history of systemic bisphosphonate therapy, pentoxyphylline or tocopherol.
•6\.Pregnancy