Osteoradionecrosis (ORN) of the irradiated mandible
Conditions
Interventions
Product Name: Oxygen
Pharmaceutical Form: Medicinal gas, compressed
INN or Proposed INN: Oxygen
CAS Number: 7782447
Other descriptive na
Sponsors
The University of Liverpool
Aintree University Hospital NHS Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 221
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: Primary endpoint will be evaluated at six months following surgery.; Main Objective: Questions in a number of key areas are addressed by this trial: 1. Incidence of ORN: what is the incidence of ORN following ‘at risk’ procedures, and how is this affected by the use of prophylactic HBO? 2. Outcome of ORN: what proportion of ORN cases progress to the most serious outcomes, and how is this influenced by the use of prophylactic HBO? 3. Morbidity of HBO: measurement of adverse events in treatment arm related to HBO therapy. 4. Cost effectiveness: what is the financial justification for prophylactic HBO in this setting? 5. Oral rehabilitation: how is osseointegrated implant retention affected by HBO independent of any effect on the incidence if ORN? 6. Late follow up of MBS (Minor Bone Spicules) to assess risk of further deterioration for patients with MBS (see Appendix 11) 7. Late follow up of implant survival: How many implants were lost since completing the HOPON assessments? (See Appendix 12). ; Secondary Objective: Secondary Outcomes: 1. The diagnosis of osteoradionecrosis at 3 and 12 months (in the same way as the 6 month outcome) 2. Severity of cases of diagnosed osteoradionecrosis, according to Notani grade 3. Pain: patient questionnaire at baseline, 3, 6 and 12 months 4. Quality of life (QoL): following randomisation, and at 3, 6 and 12 months following surgery (as determined by a modified University of Washington Head and Neck QoL questionnaire - Appendix 6) 5. Implant survival and outcome of MBS Safety Outcomes: 1. Adverse events in HBO arm related to hyperbaric oxygen treatment 2. The number and proportion of patients with hospital | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary Outcomes: 1. The diagnosis of osteoradionecrosis at 3 and 12 months (in the same way as the 6 month outcome) 2. Severity of cases of diagnosed osteoradionecrosis, according to Notani grade 3. Pain: patient questionnaire at baseline, 3, 6 and 12 months 4. Quality of life (QoL): following randomisation, and at 3, 6 and 12 months following surgery (as determined by a modified University of Washington Head and Neck QoL questionnaire - Appendix 6) 5. Implant survival and outcome of MBS Safety Outcomes: 1. Adverse events in HBO arm related to hyperbaric oxygen treatment 2. The number and proportion of patients with hospital admissions, operations and complications (e.g. major bleeding, sepsis or mortality) occurring within 12 months post-surgery. 3. New Diagnosis of cancer, either recurrent or new site within 12 months following surgery ; Timepoint(s) of evaluation of this end point: 1.Diagnosis of ORN and at 3 and 12 months following surgery 2. Severity of ORN at 3, 6 and 12 months. 3. Pain Assessment at 3, 6 and 12 months. 4. Quality of Life at 3, 6 and 12 months. 5. Adverse Events at 3, 6 and 12 months 6.Admissions, operations, complications at 3, 6 and 12 months. 7. Mortality (any time in study) 8. The number and proportion of patients with hospital admissions, operations and complications (e.g. major bleeding, sepsis or mortality) occurring within 12 months post-surgery. 9. New Diagnosis of cancer, either recurrent or new site within 12 months following surgery | — |
Countries
United Kingdom
Contacts
Public ContactClinical Trials Information
Cancer Research UK Liverpool Cancer Trials Unit
Outcome results
None listed