Effects of Stellate Ganglion Block on Hot Flashes in Hispanic Women With Breast Cancer: A Pilot Randomized Sham-Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- 2 Month Subject Reported Daily Hot Flashes (Mean)
研究概览
简要总结
Vasomotor symptoms (hot flashes, night sweats, VMS) affect up to 65% of breast cancer survivors and negatively impact their quality of life. VMS in Hispanic women are significantly more severe as compared to non-Hispanic Caucasian women. Few effective treatments for VMS are available, especially in the underserved Hispanic and Spanish-speaking populations which is problematic, as Hispanics will comprise 20% of the U.S. population by 2025. Stellate ganglion nerve block (SGB) with local anesthetic, previously performed for chronic pain indications, has shown promise as a potential treatment for menopausal women with VMS in previous clinical trials, but has not been investigated in Hispanic or Spanish-Speaking women with breast cancer in a controlled study.
详细描述
In this study, investigators aim to assess the effects of SGB on VMS, sympathetic nervous system activity, depression and sleep in Hispanic and Spanish-Speaking women with breast cancer on endocrine therapy who take tamoxifen, aromatase inhibitors (AIs) or SERMS, in a prospective, randomized, sham-controlled pilot study.
Project Hypothesis: The frequency and intensity of subjective and objective VMS will be significantly lower in women randomized to active SGB as compared to sham control.
Project Scope: Hispanic and Spanish-speaking women with breast cancer on tamoxifen, aromatase inhibitors or SERMs with moderate to severe VMS will be enrolled as participants in this study. Eligible women will be specifically recruited from the oncology practice of Dr. Cesar Santa Maria, as well as Northwestern Memorial Hospital and other Northwestern affiliates.
Specific Goals and Objectives:
Goal 1: Determine the effect of stellate ganglion blockade (SGB) for reducing subjective and objective VMS in Hispanic women with breast cancer on endocrine therapy as this population is known to have a greater severity of VMS and has been notoriously underserved and understudied in the U.S. and in clinical trials.
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
- Single (Care Provider)
入排标准
- 年龄范围
- 30 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Hispanic or Spanish speaking women aged 30 to 70 years
- •28 or more reported moderate-to-very severe hot flashes per week
- •a minimum of two weeks of VMS diary recording prior to SGB
- •current use of tamoxifen, aromatase inhibitors, or SERMs for a breast cancer indication for at last six months
- •willingness to undergo fluoroscopy-guided SGB or sham treatment.
- •if participant is on an SSRI,SNRI or membrane stabilizer (pregabalin, gabapentin, for example), it must be a stable, unchanged dose for previous 3 months
排除标准
- •conditions that preclude SGB or sham intervention (e.g., anatomic abnormalities of the anterior neck or cervical spine; goiter, cardiac/pulmonary compromise; acute illness/infection; coagulopathy or bleeding disorder; allergic reactions/contraindications to a local anesthetic or contrast dye); pregnancy
- •use of treatments in the past 2 months that can affect VMS (e.g., use of oral or transdermal HT or contraceptives,
研究组 & 干预措施
Bupivicaine
Stellate Ganglion Block Injection with bupivicaine
干预措施: Stellate Ganglion Block injection with bupivicaine (Drug)
Saline
Saline injection
干预措施: Saline (Drug)
结局指标
主要结局
2 Month Subject Reported Daily Hot Flashes (Mean)
时间窗: 2 months after treatment
2 month subject reported daily hot flashes measured from day 60 to day 90 after treatment (mean value).
次要结局
未报告次要终点
研究者
David Walega
Associate Professor of Anesthesiology
Northwestern University