Hyperbaric Oxygen for the Prevention of OsteoradioNecrosis
| ISRCTN | ISRCTN39634732 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN39634732 |
| Secondary identifying numbers | 2 |
- Submission date
- 21/05/2008
- Registration date
- 13/06/2008
- Last edited
- 18/11/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Injury, Occupational Diseases, Poisoning
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Contact information
Mr Richard Shaw
Scientific
Scientific
Regional Maxillofacial Unit
University Hospital Aintree
Lower Lane
Liverpool
L9 7AL
United Kingdom
| Phone | +44 (0)151 529 5290 |
|---|---|
| richardshaw@liv.ac.uk |
Study information
| Study design | Multicentre randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Prevention |
| Participant information sheet | Patient information can be found at: http://www.lctu.org.uk/docs/trialdocs.html |
| Scientific title | A randomised controlled trial of hyperbaric oxygen to prevent osteoradionecrosis of the irradiated mandible |
| Study acronym | HOPON |
| Study objectives | The aim of this study is to determine the benefit of hyperbaric oxygen (HBO) in the prevention of osteoradionecrosis (ORN) subsequent to a surgical procedure in the "at risk" irradiated mandible. This study is designed as a randomised control multi-centre feasibility study. |
| Ethics approval(s) | Central Manchester Research Ethics Committee on 28/04/2008 (ref: 08/H1008/32) |
| Health condition(s) or problem(s) studied | Osteoradionecrosis subsequent to a surgical procedure in an irradiated mandible |
| Intervention | Arm 1: Standard management: 1. Pre- and post-operative chlorohexidine1 mouthwash 0.2% - use 10 ml (i.e. one capful) washed around the mouth for around 1 minute and spat out, three times daily for 5 days post-operatively. 1.1. In case of chlorohexidine allergy use warm salt mouthwash at 1 teaspoon per cup of warm water. 2. Oral antibiotics: amoxicillin 3 g oral 1 hour pre-operatively (or 1 g intravenously), and 250 mg three times a day (tds) x 5 days post-operatively 2.1. In penicillin allergy: Orally either 600 mg tablet, or same dose of 75 mg/5 ml suspension if tablets not tolerated, 1 hour pre-operatively or intravenously 600 mg at time of surgery, and 200 mg metronidazole (patients should be warned of interaction between alcohol and metronidazole) tds x 5 days post-operatively Arm 2: Standard management plus HBO Patients will undergo 20 HBO treatments prior to surgery followed by a further 10 HBO treatments. HBO will comply with dive table RN66. For each HBO treatment, patients are compressed to 2.4 ata while sitting in an appropriate British Hyperbaric Association recognised hyperbaric chamber. Patients breathe 100% oxygen at pressure via a transparent hood. The total time at 2.4 ata is 90 minutes. During the final 10 minutes of oxygen breathing, the chamber is depressurised to ambient atmospheric pressure at a linear rate (14.3 kpa/min). 3. All participants will be operated with a minimally traumatic surgical technique after the standard management with or without HBO. |
| Intervention type | Other |
| Primary outcome measure | Mucosal healing and/or the presence of necrotic bone at 6 months following surgery, measured by the following: 1. Clinical assessment in centre 2. Clinical photograph with in-photograph ruler 3. Radiographic using orthopantomogram (OPT) The primary outcome will be based on a blinded assessment of anonymised clinical photograph and radiograph by a central committee consisting of experienced clinicians in the field. |
| Secondary outcome measures | 1. Mucosal healing at 3 months following surgery (measured as at 6 months following surgery) 2. Severity of cases of diagnosed osteoradionecrosis, with clinical and radiographic recordings of severity made according to the following: 2.1. Grade I: ORN confined to alveolar bone 2.2. Grade II: ORN limited to the alveolar bone and/or mandible above the level of inferior alveolar canal 2.3. Grade III: ORN involving the mandible below the level of inferior alveolar canal and ORN with a skin fistula and/or pathologic fracture 3. Pain: patient questionnaire at 3 and 6 months 4. Quality of life (QoL): prior to randomisation but following consent, and at 3 and 6 months (as determined by a modified University of Washington) 5. Head and Neck QoL questionnaire (modified) at baseline, 3 and 6 months 6. Adverse events in HBO arm related to hyperbaric oxygen treatment, monitored throughout trial 7. Admissions, operations, complications (e.g. major bleeding, sepsis), monitored throughout trial 8. Mortality. Patients will be followed up until death or 6 months. 9. Implant retention (where appropriate) and outcomes of ORN (where appropriate) at 12 and 24 months following surgery |
| Overall study start date | 01/06/2008 |
| Completion date | 31/05/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Added 22/02/2011: 200 (50 at time of registration) |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/06/2008 |
| Date of final enrolment | 31/05/2014 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Regional Maxillofacial Unit
Liverpool
L9 7AL
United Kingdom
L9 7AL
United Kingdom
Sponsor information
University of Liverpool (UK)
University/education
University/education
Foundation Building
Brownlow Hill
Liverpool
L69 7ZX
England
United Kingdom
| Phone | +44 (0)151 794 2000 |
|---|---|
| Ethics@liverpool.ac.uk | |
| Website | http://www.liv.ac.uk |
"ROR" |
https://ror.org/04xs57h96 |
Funders
Funder type
Charity
Cancer Research UK (ref: C23033/A9397)
Private sector organisation / Other non-profit organizations
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- CR_UK, Cancer Research UK - London, CRUK
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
18/11/2016: No publications found in PubMed, verifying study status with principal investigator.
22/02/2011: The anticipated end date for this trial was updated from 31/05/2010 to 31/05/2014 and the target participant number was increased from 50 to 200.
