A study looking at the treatment of patients with jaw bone damage in head and neck cancer (DAHANCA21)
- Conditions
- Mandibular Osteoradionecrosis in patients with previous head and neck cancer.MedDRA version: 18.0 Level: PT Classification code 10067352 Term: Osteoradionecrosis System Organ Class: 10022117 - Injury, poisoning and procedural complicationsTherapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2007-007842-36-GB
- Lead Sponsor
- Copenhagen University Hospital, Rigshospitalet
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 114
1.Osteoradionecrosis grade 2, 3 or 4 (CTCAE v 3.0.)
2.Mandible Site
3.Age > 18
4. Patient has read and understood information leaflet and is willing to be randomised.
5.Patient competent to consent and psychologically / physically fit for HBO.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 80
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 34
No contraindications for hyperbaric oxygen treatment, e.g. emphysema, uncontrolled asthma, epilepsy, previous optic neuritis
Exclusion criteria solely apply for HBO treatment. Should any criteria arise after the HBO treatment, it is unnecessary to withdraw the patient from participation.
1.Malignancy/residual cancer
2.Previous HBO treatment
3.Pregnancy or lactation (fertile female participants are required to use safe contraception)
4.Unmanageable claustrophobia
5.Undrained pneumothorax
6.Uncontrollable hypertension or blood pressure >220/110
7.Exposure of titanium reconstruction device
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method