Hyperbaric Oxygen to Prevent Osteoradionecrosis of the Irradiated Mandible (HOPON) - HOPO

The University of Liverpool0 个研究点目标入组 144 人开始时间: 2008年3月26日最近更新: 2019年2月28日

适应症

试验速览

暂无简介。

•1.Age > 18 years
•2.Prior history of external beam radiotherapy (dose > 50Gy) to mandible or prior history of brachytherapy with equivalent radiation dose as above.
•3.No evidence of cancer recurrence
•4.New diagnosis of 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.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 221
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 221

•1.Known contraindications to HBO:
•a.Lung disease: Chronic obstructive airways disease; bullous lung disease, acute or chronic pulmonary infection; uncontrolled asthma, untreated pneumothorax
•b.Middle ear disease; previous middle ear operations, eustachian tube dysfunction or recurrent attacks of vertigo
•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

发起方

The University of Liverpool