Effects of Stellate Ganglion Block (SGB) on Vasomotor Symptoms in Women Receiving Anti-Estrogen Therapy for Breast Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- Change in Number of Night Sweats From Baseline to 6 Months After Intervention.
研究概览
简要总结
Vasomotor symptoms (VMS) affect up to 65% of breast cancer survivors and negatively impact their quality of life. The investigators aim to evaluate the benefit of SGB in symptomatic women with breast cancer who are on anti-estrogens and are seeking relief from moderate to very severe VMS that are adversely affecting health and wellbeing. Women with breast cancer on Tamoxifen, aromatase inhibitors (AIs) or Selective Estrogen Receptor Modulators (SERMS) with moderate to very severe VMS will be enrolled as participants in this study.
详细描述
Hypotheses: The frequency and intensity of subjective and objective VMS will be significantly lower in women randomized to active SGB as compared to sham controls. Mood, memory, cognition, sleep, and quality of life will all be improved in the treatment group as compared to the sham-control group.
Specific Goals and Objectives:
Goal 1: To determine the effect of stellate ganglion blockade (SGB) for reducing subjective and objective VMS in women with breast cancer on tamoxifen, AIs, or SERMs Goal 2: To evaluate the effect of SGB on mood, memory, cognition, sleep and quality of life in women with breast cancer on tamoxifen, AIs, or SERMs.
We aim to conduct a randomized, single-site, sham-control clinical trial of SGB on VMS in 30 women with breast cancer on anti-estrogen therapy (15 per group). The primary entry criterion will be 28 or more moderate to very severe hot flashes per week. VMS will be measured by self-report on a written daily dairy over a 6-month period. Secondary outcomes include changes in mood, sleep, quality of life, and objective hot flashes measured by ambulatory monitoring (skin-conductance temperature monitoring) for 24 hours at baseline, three months and six months. Memory performance with neurocognitive testing will be done at baseline and 3 months.
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
- •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.
- •Approval of healthcare provider if ≥ 21 for depression and ≥15 for anxiety on the Depression Anxiety and Stress Scale (DASS)
- •Stable use of Selective Serotonin Reuptake Inhibitors (SSRIs), Selective Norepinephrine Reuptake Inhibitors (SNRIs) if applicable
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);
- •use of treatments in the past two months that can affect VMS (e.g., use of oral or transdermal Hormone Treatment (HT) or contraceptives, SERMS,
- •conditions or disorders that can affect performance on cognitive tests (e.g., dementia/mild cognitive impairment; stroke; traumatic brain injury; alcohol/substance use; inability to write, speak, or read in English, English as a second language
- •Mini-Mental State Exam (MMSE) ≥ 28
- •conditions that can affect sleep quality (e.g., use of sleep agents; shift work; etc.)
研究组 & 干预措施
Bupivicaine
Stellate Ganglion Block injection with 10 mL .5 % bupivacaine.
干预措施: Bupivicaine (Drug)
Saline
Saline injection (.9 normal saline) 5 ml.
干预措施: Saline (Drug)
结局指标
主要结局
Change in Number of Night Sweats From Baseline to 6 Months After Intervention.
时间窗: 6 months after intervention
Change in number of mean night sweats from baseline to 6 months after intervention using a paper diary (subjective measure of frequency). Number is the change from mean baseline number of night sweats to mean 6 months after procedure (number of ns/month)
Intensity of Subjective Hot Flashes (HF) at Baseline and 6 Months
时间窗: 6 months after stellate ganglion block procedure
Hot flashes intensity from baseline and at 6 months as reported by the subject using paper diary (subjective) measures of intensity (including mild, severe and very severe HF).Intensity scoring = Frequency\*Severity = \[(frequency of mild\*1)+(frequency of moderate\*2) + (frequency of severe\*3) + (frequency of very severe\*4)\]. Mean intensity of hot flashes at baseline and 6 months. Score on a unlimited scale of 0- infinity based on number of hot flashes. A score on the scale where 0 is good higher scores are worse.
Change in Number of Hot Flashes From Baseline to 6 Months After Intervention. [Time Frame: 6 Months After Intervention]
时间窗: 6 months after intervention
Mean change in number of hot flashes from baseline to 6 months after intervention using a paper diary (subjective measure of frequency). Number is the change from mean baseline number of hot flashes to mean 6 months after procedure (number of ns/month)
次要结局
- Changes From Baseline of Pittsburg Sleep Quality Inventory (PSQI)(6 month following intervention)
- Survey Score Changes From Baseline to 6 Months After Intervention Using the Epidemiological Studies-Depression(CES-D) Survey.(6 months following intervention)
研究者
David Walega
Associate Professor of Anesthesiology; Chief,Section of Pain Medicine
Northwestern University