NCT00682747终止2 期
Randomized Phase II Trial of Hyperbaric Oxygen for the Treatment of Radiation-induced Xerostomia
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- Thomas Kuhnt
- 入组人数
- 13
- 试验地点
- 2
- 主要终点
- change of overall salivation (millilitre per minute over 5 minutes measured at rest and after provocation) in percentages
研究概览
简要总结
The purpose of this study is to determine whether hyperbaric oxygen is effective in the treatment of a dry mouth that occured after radiotherapy for head and neck tumours.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •complaints of xerostomia (visual analogue scale)
- •at least 6 months after radiotherapy of the head and neck region including all salivary glands with at least 50 Gy
- •objective hyposalivation / xerostomia (at rest < 0,25 ml saliva per minute, stimulated < 0,1 ml saliva per minute)
- •patient must have given written informed consent
排除标准
- •prior radiotherapy was an intensity modulated radiotherapy
- •prior hyperbaric oxygen therapy after radiotherapy
- •conditions which might be an additional risk for the treatment with hyperbaric oxygen such as spontaneous pneumothorax within the last two years, surgery of the eardrum or the middle ear, acute infection of the upper airways, not adequately treated epilepsy, concurrent radio- or chemotherapy, hereditary spherocytosis, psychosis, lung emphysema, asthma, severe COPD, prior surgery of the thorax, pace maker
- •myocardial infarction within the last 6 months
- •drug therapy which might induce xerostomia
- •known intolerance or hypersensitivity to Wrigley's Freident®
- •pregnancy or breast-feeding women (for women aged less than 60 years a pregnancy test is mandatory)
- •women of childbearing potential with unclear contraception. The following contraceptive methods are recommended: combined oral contraceptives or progesterone-only pill, hormone-dispensing or copper intra-uterine system, hormone patches, long-acting injections, vaginal ring
- •treatment with other investigational drugs or participation in another clinical trial within 30 days prior to enrollment
- •refusal of cooperation or consent
研究组 & 干预措施
HBO
Experimental
40 treatments with hyperbaric oxygen once per day, five days per week, 2.4 ATA, 100 % oxygen (10-15 minutes compression with air, 90 min of oxygen breathing - two 10 minutes break for breathing air after each 30 minutes of oxygen, 10 minutes decompression with oxygen)
干预措施: Hyperbaric oxygen (Drug)
结局指标
主要结局
change of overall salivation (millilitre per minute over 5 minutes measured at rest and after provocation) in percentages
时间窗: baseline compared with measures on day 28, 56 and 146
次要结局
- Improvement of symptoms/discomfort due to xerestomia assessed by the patient on a visual analogue scale(baseline compared with measures on day 28, 56 and 146)
- Number of Adverse Events in all patients as a Measure of Safety and Tolerability(baseline until 4 weeks after end of study treatment)
- Xerostomia scores assessed by investigator according to Eisbruch et.al.(baseline compared with measures on day 28, 56 and 146)
- quality of life measures (EORTC QLQ-H&N 35)(baseline compared with measures on day 28, 56 and 146)
研究者
Thomas Kuhnt
Dr. med.
Martin-Luther-Universität Halle-Wittenberg
研究点 (2)
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