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

• Status: Recruiting
• Trial end date: 2022-07-01
• Target enrollment: 0
• Participant gender: Female

Summary

Vasomotor symptoms (hot flashes, night sweats, VMS) affect up to 65% of breast cancer survivors and negatively impact their quality of life. VMS in Hispanic women are significantly more severe as compared to non-Hispanic Caucasian women. Few effective treatments for VMS are available, especially in the underserved Hispanic and Spanish-speaking populations which is problematic, as Hispanics will comprise 20% of the U.S. population by 2025. Stellate ganglion nerve block (SGB) with local anesthetic, previously performed for chronic pain indications, has shown promise as a potential treatment for menopausal women with VMS in previous clinical trials, but has not been investigated in Hispanic or Spanish-Speaking women with breast cancer in a controlled study.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Northwestern University
• Collaborators: Indiana University; University of Illinois at Chicago
• Treatments: Bupivacaine

Criteria

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,

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