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HOPON   

Title

HOPON: Hyperbaric Oxygen for the Prevention of Osteoradionecrosis.


Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs
III Treatment FollowUp Over 18 University of Liverpool and Aintree University Hospitals NHS Foundation trust Eudract No: 2007-006225-27
Isrctn No: 39634732

Purpose

One complication of radiotherapy for head and neck cancer is osteoradionecrosis (ORN) of the jaws. Osteoradionecrosis (ORN) describes the process where irradiated bone undergoes necrosis and becomes exposed through the investing soft tissues for a period of at least 3 months. The most important risk factor for ORN is surgical trauma, commonly dental extractions in an irradiated jaw, but ORN can also occur spontaneously. ORN is painful and debilitating, sometimes requiring surgical resection of the jaw and/or hyperbaric oxygen (HBO) treatments. The morbidity and mortality of osteoradionecrosis is significant and treatment outcomes often unsatisfactory.


Trial Lead Organisations

  • University Hospital Aintree NHS Foundation Trust
  • University of Liverpool
  • Chief Investigator: Mr Richard Shaw


Trial Start Date

16/09/2008


Trial Coordinator

Binyam Tesfaye


Trial Coordinator Email Address

btesfaye@liverpool.ac.uk


Trial Coordinator Contact No

0151 795 5479


Website Treatment  

Patients will be randomised to receive treatment from one of the following treatment arms: 1) Oral antibiotics and mouthwashes (pre and post surgery), and surgery; or 2) Hyperbaric oxygen (HBO) treatment plus oral antibiotics and mouthwashes (pre and post surgery), and surgery. Patients randomised to the HBO treatment arm of the trial will receive 20 pre-op HBO �dives� followed by 10 post-op HBO �dives� at a hyperbaric unit.

Trial Endpoints  

To determine the benefit of HBO in the prevention of osteoradionecrosis (ORN) subsequent to a surgical procedure in the "at risk" irradiated mandible


Primary Outcome  

  • Mucosal healing at 6 months following surgery


Secondary Outcomes  

  • Diagnosis of ORN at 3 and 12 months following surgery (measured by clinical assessment, clinical photograph and *radiograph using OPT [*in cases of no mucosal healing] ).
  • Severity of cases of diagnosed osteoradionecrosis, with clinical and radiographic recordings of severity made according to: Notani K. et al., Head & Neck 2003: 25:181-186
  • Pain: patient questionnaire at 3,6 and 12 months
  • Radiographic appearance: orthopantomogram (OPT) at baseline and 6 months for all patients. OPT at 3 and 12 months in cases where there is no mucosal healing only.
  • Clinical photographs at baseline, 3, 6 and 12 months
  • Quality of life (QoL): at baseline, 3, 6 and 12 months following surgery (as determined by the University of Washington Head and Neck QoL questionnaire)
  • Adverse events in HBO arm related to hyperbaric oxygen treatment
  • Admissions, operations, complications (e.g. major bleeding, sepsis)
  • Mortality
  • Implant retention (where appropriate) and outcomes of ORN (where appropriate) at 3, 6 and 12 months following surgery
  • New diagnosis of cancer, either recurrent or new site at 3, 6 and 12 months following surgery

Eligibility  

  • Age > 18 years
  • Prior history of external beam radiotherapy (dose > 50Gy) to mandible or prior history of brachytherapy with equivalent radiation dose as above.
  • No evidence of cancer recurrence
  • Condition requiring surgery to mandible (commonest examples but not limited to: dental extraction, implant placement, surgical tooth removal, cyst enucleation)
  • Patient has read and understood information leaflet and is willing to be randomised.
  • Patient competent to consent and psychologically / physically fit for HBO.
  • No known contraindications to HBO
    • Lung disease: Severe chronic obstructive airways disease; bullous lung disease, acute or chronic pulmonary infection; uncontrolled asthma, untreated pneumothorax
    • Middle ear disease (such as previous middle ear operations, eustachian tube dysfunction or recurrent attacks of vertigo) that proves refractory to simple interventions such as grommet insertion
  • No prior hyperbaric oxygen therapy
  • No prior diagnosis of osteoradionecrosis of the mandible
  • No previous surgery for osteoradionecrosis
  • No history of systemic bisphosphonate therapy, pentoxyphylline or tocopherol.
  • Not Pregnancy

DENMARK

  • Copenhagen, Copenhagen University Hospital (Lone Forner)

UK: ENGLAND

  • Birmingham, University Hospital Birmingham (Prav Praveen)
  • Bradford, Bradford Teaching Hospitals NHS Foundation Trust (Michael Ho)
  • Bristol, Bristol Haematology and Oncology Centre (Matthew Beasley)
  • Chichester, St. Richard's Hospital (Chichester) (Madan Ethunandan)
  • Chichester, St. Richard's Hospital (Chichester) (Peyman Alam)
  • Exeter, Royal Devon & Exeter Hospital (John Bowden)
  • Gloucester, Gloucestershire Royal Hospital (Gloucester) (Charles Perkins)
  • Kingston Upon Hull, North of England Hyperbaric Service (Kingston Upon Hull) (Gerard Purdy)
  • Leeds, Leeds General Infirmary (Peter Nixon)
  • Liverpool, University Hospital Aintree (Richard Shaw)
  • London, Guy's & St Thomas' Hospital (London) (Mark McGurk)
  • London, Guy's & St Thomas' Hospital (London) (Andrew Lyons)
  • Manchester, North Manchester General Hospital (Robert Woodwards)
  • Plymouth, The Hyperbaric Medical Centre (Plymouth) (Christine Penny)
  • Portsmouth, Queen Alexandra Hospital (Portsmouth) (Peter Brennan)
  • Wirral, North West Emergency Recompression Unit, Murrayfield Hospital (Wirral) (John Harrison)
  • Wirral, North West Emergency Recompression Unit, Murrayfield Hospital (Wirral) (Tristan Cope)

UK: SCOTLAND

  • Aberdeen, Aberdeen Royal Infirmary (Ruth Stephenson)

UK: WALES

  • Cardiff, South Wales Hyperbaric Medical Centre, Spire Cardiff Hospital (Mihaela Ignatescu)
  • Cardiff, South Wales Hyperbaric Medical Centre, Spire Cardiff Hospital (Christine Penny)
  • Newport, Royal Gwent Hospital (Newport) (Ian Richard Parkin)
  • Rhyl, Glan Clwyd Hospital (Rhyl) (Chris Lloyd)

NETHERLANDS

  • NL- 1066 CX Asmterdam, The Netherlands Cancer Institute Antoni van Leeuwenhoek Hospital (Ludi Smeele)

UK: ENGLAND

  • Harrow, Northwick Park Hospital (Harrow) (Bhavin Visavadia)
  • London, Royal Marsden Hospital (London) (Cyrus Kerawala)
  • Rugby,, Hospital of St Cross - Midlands Diving Chamber (Rugby) (Michael Gonevski)

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