Effects of Stellate Ganglion Block on Hot Flashes in Hispanic Women With Breast Cancer

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.

Goal 2: Evaluate the effect of SGB on the sympathetic nervous system over time to gain new
knowledge on the physiologic mechanism of SGB effects on VMS.

Goal 3: Evaluate the effect of SGB on mood, sleep, and quality of life in women with breast
cancer on tamoxifen, AIs, or SERMs.

Goal 4: Using the results of this pilot study, investigators plan to submit an R01 grant to
the National Cancer Institute in 2017 for a larger scale study.

Inclusion Criteria:

1. Hispanic or Spanish speaking women aged 30 to 70 years

2. 28 or more reported moderate-to-very severe hot flashes per week

3. a minimum of two weeks of VMS diary recording prior to SGB

4. current use of tamoxifen, aromatase inhibitors, or SERMs for a breast cancer
indication for at last six months

5. willingness to undergo fluoroscopy-guided SGB or sham treatment.

6. 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

Exclusion Criteria:

1. 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 2. use of treatments in the past 2 months
that can affect VMS (e.g., use of oral or transdermal HT or contraceptives,