NCT01606644Unknown3 期
Hyperbaric Oxygen - a New Treatment Modality in Patients With Radiation Damaged Salivary Gland Tissue.
Lone Forner2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2010年5月最近更新:
适应症
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Salivation rate
研究概览
简要总结
Randomized clinical trial regarding the effect of hyperbaric oxygen on late radiation tissue injury to salivary gland tissue.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Surgical treatment of head and neck cancer
- •Salivary gland disease
- •Severe claustrophobia
- •Pregnancy or lactation (fertile women must use safe contraceptives)
- •Uncontrolled hypertension (> 220/110)
- •Lack of ability to equalize inner ear pressure
- •Pneumothorax
- •Thoracic surgery within one month before HBO treatment
- •Abuse of alcohol, drugs or narcotics
- •Exposed titanium surfaces or defect titanium in the oral cavity
- •Previous HBO treatment
结局指标
主要结局
Salivation rate
时间窗: 6 months
次要结局
- Xerostomia(6 months)
- Quality of life(6 months)
研究者
Lone Forner
DDS, PhD
Rigshospitalet, Denmark
研究点 (2)
Loading locations...
相似试验
已完成
不适用
Hyperbaric Oxygen Radiation Tissue Injury Study - IV (Radiation proctitis)Radiation ProctitisRadiation tissue injury caused by radiotherapy for cancerCancerISRCTN85456814Baromedical Research Foundation (USA)150
已完成
不适用
Hyperbaric Oxygen Radiation Tissue Injury Study - VII (Laryngeal radionecrosis)ISRCTN01022468Baromedical Research Foundation (USA)42
已完成
不适用
Hyperbaric Oxygen Radiation Tissue Injury Study - VIII (Prophylaxis)Radiation prophylaxisUnspecified effects of radiationCancerISRCTN46000377Baromedical Research Foundation (USA)38
已完成
不适用
Hyperbaric Oxygen Radiation Tissue Injury Study - I (Soft tissue radionecrosis)Soft tissue radionecrosisUnspecified effects of radiationCancerISRCTN02327449Baromedical Research Foundation (USA)60
Unknown
2 期
Hyperbaric Oxygen Therapy Compared With Standard Therapy in Treating Chronic Arm Lymphedema in Patients Who Have Undergone Radiation Therapy for CancerLymphedemaPerioperative/Postoperative ComplicationsRadiation FibrosisBreast CancerNCT00077090Institute of Cancer Research, United Kingdom63