Hot Flashes Clinical Trial
Official title:
Effects of Stellate Ganglion Block on Hot Flashes in Hispanic Women With Breast Cancer: A Pilot Randomized Sham-Controlled Trial
Verified date | July 2022 |
Source | Northwestern University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 2 |
Est. completion date | July 1, 2020 |
Est. primary completion date | July 1, 2020 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 30 Years to 70 Years |
Eligibility | 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, - |
Country | Name | City | State |
---|---|---|---|
United States | Anesthesiology Pain Medicine Center | Chicago | Illinois |
Lead Sponsor | Collaborator |
---|---|
Northwestern University | Indiana University, University of Illinois at Chicago |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 2 Month Subject Reported Daily Hot Flashes (Mean) | 2 month subject reported daily hot flashes measured from day 60 to day 90 after treatment (mean value). | 2 months after treatment |
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