Stellate Ganglion Block (SGB) For Women for Breast Cancer

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.

Inclusion Criteria:

1. 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. Approval of healthcare provider if ≥ 21 for depression and ≥15 for anxiety on the
Depression Anxiety and Stress Scale (DASS)

7. Stable use of Selective Serotonin Reuptake Inhibitors (SSRIs), Selective
Norepinephrine Reuptake Inhibitors (SNRIs) if applicable

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);

2. 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,

3. 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

4. Mini-Mental State Exam (MMSE) ≥ 28

5. conditions that can affect sleep quality (e.g., use of sleep agents; shift work; etc.)