ISRCTN39634732
Completed
Phase 3
A randomised controlled trial of hyperbaric oxygen to prevent osteoradionecrosis of the irradiated mandible
niversity of Liverpool (UK)0 sites200 target enrollmentJune 13, 2008
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- niversity of Liverpool (UK)
- Enrollment
- 200
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Both males and females, age \>18 years
- •2\. Prior history of external beam radiotherapy (dose \>50 Gy) to mandible or prior history of brachytherapy with equivalent radiation dose as above
- •3\. No evidence of cancer recurrence
- •4\. 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
Exclusion Criteria
- •1\. Known contraindications to HBO:
- •1\.1\. Lung disease: Severe chronic obstructive airways disease; bullous lung disease, acute or chronic pulmonary infection; uncontrolled asthma, untreated pneumothorax
- •12\. 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
- •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
Outcomes
Primary Outcomes
Not specified
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