EUCTR2008-001972-55-NL进行中（未招募）1 期
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 个研究点目标入组 128 人开始时间: 2008年6月11日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 128
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •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
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