Short-term Efficacy of Stellate Ganglion Block in Men to Reduce Hot Flushes Related to Androgen Deprivation Therapy
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 2
- 主要终点
- Hot flush score
研究概览
简要总结
Androgen deprivation therapy (ADT) is widely used as standard therapy in the treatment of locally advanced and metastatic prostate cancer. Hot flushes and night sweats are one of the main side-effects of ADT. There are no successful and well-tolerable treatment options available. A possible treatment for hot flushes is stellate-ganglion block (SGB), used as a means of interrupting parts of the sympathetic nervous system involved in temperature regulation.
Objective of this study:
To assess the short-term efficacy of stellate ganglion block on hot flush reduction versus sham procedure
详细描述
Androgen deprivation therapy (ADT) is widely used as standard therapy in the treatment of locally advanced and metastatic prostate cancer. Hot flushes and night sweats are one of the main side-effects of ADT. There are no successful and well-tolerable treatment options available. A possible treatment for hot flushes is stellate-ganglion block (SGB), used as a means of interrupting parts of the sympathetic nervous system involved in temperature regulation.
Objective of this study
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Age: >18 years
- •Mean daily flush frequency of 10 or more and a hot flush score of 15 or more
- •Treatment with ADT because of prostate cancer
- •Absence of any other cause of flushing
排除标准
- •Use of medication that affects flushing: oestrogens, progestogens, clonidine, naloxone, paroxetine, fluoxetine, venlafaxine, gabapentin, luteinizing hormone-releasing hormone receptor antagonist
- •Still receiving chemotherapy of radiotherapy
- •Psychiatric disease
- •Any unstable concurrent disease
- •Allergic reactions against bupivacaine or contrast media.
结局指标
主要结局
Hot flush score
时间窗: 4 weeks
次要结局
未报告次要终点
研究者
Jan Willem Kallewaard phd
Principal Investigator
Rijnstate Hospital