Overview

Stellate Ganglion Block (SGB) For Women for Breast Cancer

Status:
Active, not recruiting

Trial end date:
2022-06-01

Target enrollment:
0

Participant gender:
Female

Summary

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.

Phase:

Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Northwestern University

Collaborator:

University of Illinois at Chicago

Treatments:

Bupivacaine
Estrogen Antagonists
Estrogen Receptor Modulators
Estrogens

Criteria

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.)