Hyperbaric Oxygen Treatment of Mandibular Osteoradionecrosis. A Randomized Clinical Study
1 other identifier
interventional
114
3 countries
4
Brief Summary
There is currently not sufficient evidence that hyperbaric oxygen (HBO) benefits the surgical removal of necrotic bone in osteoradionecrosis patients. This study aims at testing the hypothesis that HBO does improve healing after surgical removal of necrotic bone in irradiated previous head and neck cancer patients compared to not receiving HBO.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jun 2008
Longer than P75 for phase_2
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2008
CompletedFirst Submitted
Initial submission to the registry
September 25, 2008
CompletedFirst Posted
Study publicly available on registry
September 26, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2015
CompletedMay 25, 2012
May 1, 2012
6.8 years
September 25, 2008
May 23, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Osteoradionecrosis status according to the National Cancer Institute Common Toxicity Criteria v 3.0
1 year
Secondary Outcomes (6)
Life Quality
1 year
Body mass index
1 year
Pain intensity
1 year
Trismus
1 year
Xerostomia
1 year
- +1 more secondary outcomes
Study Arms (2)
1
EXPERIMENTAL30 preoperative HBO sessions, sequestrectomy and 10 postoperative HBO sessions. The duration of each session is 90 minutes. 100 % oxygen is inhaled during decompression to 2.4 ATA.
2
NO INTERVENTIONSequestrectomy without HBO treatment
Interventions
30 preoperative and 10 postoperative HBO sessions 90 minutes each. Sequestrectomy is performed after 30 sessions.
Eligibility Criteria
You may qualify if:
- Osteoradionecrosis grade 2, 3 or 4 according to the CTCAE v 3.0 criteria
- Localized to the mandibula
- \> 18 yrs old
You may not qualify if:
- Existing malignant disease
- Previous HBO
- Pregnancy or lactation
- Uncontrollable claustrophobia
- Undrained pneumothorax
- Blood pressure \> 220/110
- Exposed titanium reconstruction device
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Lone Fornerlead
Study Sites (4)
Aarhus University Hospital
Aarhus, Denmark
Department of Anaesthesia, Copenhagen University Hospital
Copenhagen, 2100, Denmark
Sahlgrenska Universitet
Gothenburg, Sweden
Aintree University Hospital
Liverpool, United Kingdom
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lone Forner, DDS, PhD
Copenhagen University Hospital at Herlev
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- DDS, PhD
Study Record Dates
First Submitted
September 25, 2008
First Posted
September 26, 2008
Study Start
June 1, 2008
Primary Completion
April 1, 2015
Study Completion
April 1, 2015
Last Updated
May 25, 2012
Record last verified: 2012-05