EUCTR2008-001972-55-NL
Active, not recruiting
Phase 1
Efficacy of hyperbaric oxygen therapy in the treatment of late radiation damage, osteoradionecrosis, of the lower jaw. - Efficacy of hyperbaric oxygen therapy in the treatment of osteoradionecrosis of the jaw
MC St Radboud0 sites128 target enrollmentJune 11, 2008
ConditionsOsteoradionecrosis of the jaw due to previous radiotherapy treatment in the head and neck region
DrugsMedical Oxygen
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Osteoradionecrosis of the jaw due to previous radiotherapy treatment in the head and neck region
- Sponsor
- MC St Radboud
- Enrollment
- 128
- Status
- Active, not recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Informed consent
- •age \>18yrs
- •WHO performance status 0\-2
- •Last radiotherapy treatment 6 months or more ago.
- •Radiotherapy with curative intent \> 55Gy. Osteoradionecrosis in primary radiotherapy field.
- •No signs of local recurrence or primary tumour
- •Necrosis of the jaw and / or bone exposition of at least 1 cm, non\-healing extraction wound, dehiscence of the alveolar proces or linea mylohyoidea.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
Exclusion Criteria
- •Hyperbaric oxygen treatment in medical history
- •Bisphosphonate treatment in medical history
- •Re\-radiation
- •Osteosynthesis material in the affected area
- •Distant metastases
- •Local recurrence or primary tumour
- •Synchronous preventive treatment (extraction
Outcomes
Primary Outcomes
Not specified
Similar Trials
Completed
Not Applicable
The effectiveness of hyperbaric oxygen therapy to the final outcome of patients with sudden sensorineural hearing loss.ACTRN12616001359426Medical School of Aristotle University of Thessaloniki50
Active, not recruiting
Not Applicable
Effectiveness of hyperbaric oxygen therapy in the treatment of the open tibial fractures. Open clinical trial, randomized, prospective and controlled.EUCTR2011-003697-93-ESHospital Universitario de Canarias
Completed
Not Applicable
The efficacy of hyperbaric oxygenation therapy to crush injury:A randomized controlled clinical trialJPRN-UMIN000006903Gifu University100
Not yet recruiting
Not Applicable
Benefit of pressurised oxygen in treatment of ulcer due to pressureCTRI/2022/02/040122Department of Anaesthesiology and Critical Care
Not yet recruiting
Phase 3
The effect of Hypbaric oxygen therapy in the treatment of hidradenitis suppurativa: a randomised controlled trialacne inversafox-den disease10040792NL-OMON55331Gelre Ziekenhuizen100