Hyperbaric oxygen treatment of mandibular osteoradionecrosis. A randomized clinical study. - DAHANCA 21 (version 1)

Copenhagen University Hospital, Rigshospitalet0 个研究点目标入组 114 人开始时间: 2012年11月30日最近更新: 2019年2月28日

试验速览

暂无简介。

•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

发起方

Copenhagen University Hospital, Rigshospitalet