Does Stellate Ganglion Blockade (SGB) in Men Treated for Prostate Cancer Improve Hot Flashes? A Pilot Prospective Cohort Study
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Hot Flash Frequency Change Baseline to 3 Months After Treatment.
研究概览
简要总结
Androgen Deprivation Therapy (ADT) is a critical component of advanced prostate cancer treatment but causes numerous adverse effects including decreased bone mass, decreased muscle mass, gynecomastia, erectile dysfunction, loss of sexual desire, depression, disordered sleep, urinary symptoms, and hot flashes (HF). HF are unpleasant paroxysmal episodes of flushing, sweating with vasodilation of the face, neck, and chest. These episodes can last for seconds to minutes and are often associated with night sweats, anxiety, and insomnia and have negative effects on quality of life.
Stellate ganglion blockade (SGB) with local anesthetic may be an effective treatment of HF in men on ADT, but has not been studied in any published clinical trials.
The stellate ganglion is a neural structure in the anterior cervical spine region and is part of the sympathetic nervous system. It has been injected safely in the practice of pain management for more than 50 years in cases of post herpetic neuralgia (shingles), complex regional pain syndrome (CRPS) and other painful neuropathies as well as some types of cardiac dysrhythmias.
Given the frequency and severity and interference of HF in men on ADT for prostate cancer, in addition to the negative effects HF impose on this patient population and a paucity of effective treatments, finding alternative treatments for HF in this population is needed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Men with prostate cancer (with or without metastatic disease) on ADT for at least 2 months
- •Age less than 65 years
- •Body Mass Index (BMI) less than 32
- •Willingness to undergo image guided intervention
- •Greater than 28 hot flashes per week.
排除标准
- •Conditions that preclude SGB or sham intervention (e.g., anatomic abnormalities of the anterior neck or cervical spine; metastatic disease in or near the cervical spine; goiter;cardiac/pulmonary compromise; sleep apnea; acute illness/infection; coagulopathy or bleeding disorder; allergic reactions/contraindications to a local anesthetic or contrast dye)
- •Current treatment of prostate cancer with radium or chemotherapy
- •Use of treatments in the past two months that can affect HF (e.g., testosterone or androgen supplementation) Note: SSRIs, serotonin norepinephrine uptake inhibitors, and membrane stabilizers will be allowed but must be on stable unchanged dose for at least 8 weeks)
- •Inability to write, speak, or read in English
研究组 & 干预措施
.5% Bupivacaine
Guided right sided stelate ganglion block using .5% bupivacaine (5mLs)
干预措施: .5% Bupivacaine (Drug)
结局指标
主要结局
Hot Flash Frequency Change Baseline to 3 Months After Treatment.
时间窗: 3 months after SGB procedure
Change in mean daily hot flashes using a self-report hot flash diary from baseline to 3 months after stellate ganglion block.
次要结局
- Change in Hot Flash Severity Baseline to 3 Months After Stellate Ganglion Block(3 months after stellate ganglion block)
- Patient Global Impression of Change Score (PGIC)(4 weeks after stellate ganglion block)
- PROMIS SF4a Score 4 Weeks After Stellate Ganglion Block.(4 weeks after stellate ganglion block)
研究者
David Walega
Principal Investigator
Northwestern University