Stellate Ganglion Block (SGB) For Women for Breast Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Effects of Stellate Ganglion Block (SGB) on Vasomotor Symptoms in Women Receiving Anti-Estrogen Therapy for Breast Cancer

Conditions
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Hot Flushes, Hot Flashes

Intervention / Treatment
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* Drug: Bupivicaine
* Drug: Saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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.)

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Bupivicaine<br>Stellate Ganglion Block injection with 10 mL .5 % bupivacaine. | Drug: Bupivicaine<br>* A computer-generated 1:1 block randomization scheme will be used to assign participants to receive bupivacaine. Randomization will be performed by the injectionist immediately before the injection procedure by opening an opaque envelope to reveal the participant number and group assignment printed on an index card.10 mL .5% bupivicaine will be administered.<br>* Other names: Marcaine;|
| Sham Comparator: Saline<br>Saline injection (.9 normal saline) 5 ml. | Drug: Saline<br>* A computer-generated 1:1 block randomization scheme will be used to assign participants to receive saline. Randomization will be performed by the injectionist immediately before the injection procedure by opening an opaque envelope to reveal the participant number and group assignment printed on an index card. 5 mL sterile normal saline will be administered.<br>* Other names: Sodium chloride solution;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Number of Night Sweats From Baseline to 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) | 6 months after intervention | 
| Change in Number of Hot Flashes From Baseline to 6 Months After Intervention. [Time Frame: 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) | 6 months after intervention | 
| Intensity of Subjective Hot Flashes (HF) at Baseline and 6 Months | 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. | 6 months after stellate ganglion block procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survey Score Changes From Baseline to 6 Months After Intervention Using the Epidemiological Studies-Depression(CES-D) Survey. | Baseline score change compared to the 6 month survey score using the Epidemiological Studies-Depression(CES-D) survey. This survey is a 20-item measure that asks to rate how often over the past week they experienced symptoms associated with depression, such as restless sleep, poor appetite, and feeling lonely. Response options range from 0 to 3 for each item (0 = Rarely or None of the Time, 1 = Some or Little of the Time, 2 = Moderately or Much of the time, 3 = Most or Almost All the Time). Scores range from 0 to 60, with high scores indicating greater depressive symptoms. CES-D also provides cutoff scores (e.g., 16 or greater) that aid in identifying individuals at risk for clinical depression | 6 months following intervention | 
| Changes From Baseline of Pittsburg Sleep Quality Inventory (PSQI) | Change in Pittsburg Sleep Quality Inventory (PSQI) between baseline and 6 months post intervention. In scoring the PSQI, seven component scores are derived, each scored 0 (no difficulty) to 3 (severe difficulty). The component scores are summed to produce a global score (range 0 to 21). Higher scores indicate worse sleep quality. | 6 month following intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast Cancer, Anti-estrogens, Hot Flushes, Tamoxifen, Aromatase inhibitors, Hot Flashes