Stellate Ganglion Blockade with Bupivacaine Hydrochloride in Reducing Hot Flashes in Hispanic Patients with Breast Cancer
- Hispanic or Spanish speaking women
- 28 or more reported moderate-to-very severe hot flashes per week
- A minimum of two weeks of VMS diary recording prior to SGB
- Current use of tamoxifen, aromatase inhibitors, or SERMs for a breast cancer indication for at last six months
- Willingness to undergo fluoroscopy-guided SGB or sham treatment
- If participant is on a selective serotonin reuptake inhibitor (SSRI), serotonin-norepinephrine reuptake inhibitor (SNRI) or membrane stabilizer (pregabalin, gabapentin, for example), it must be a stable, unchanged dose for previous 3 months
- 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
- Use of treatments in the past 2 months that can affect VMS (e.g., use of oral or transdermal hormone therapy [HT] or contraceptives)
- Adults unable to consent
- Individuals who are not yet adults (infants, children, teenagers)
- Pregnant women
I. Determine the effect of stellate ganglion blockade (SGB) for reducing subjective and objective vasomotor symptoms (VMS) in Hispanic women with breast cancer on endocrine therapy (tamoxifen, aromatase inhibitors, selective estrogen receptor modulators [SERMs]).
II. 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.
III. Evaluate the effect of SGB on mood, and quality of life in these women with breast cancer using measures that have been previously validated in this population.
OUTLINE: Participants are randomized to 1 of 2 groups.
GROUP I: Participants receive bupivacaine hydrochloride subcutaneously (SC) and undergo a fluoroscopy-guided SGB at baseline and optionally at 3 months. Participants also wear a hot flash monitor and actigraph watch for 6 months.
GROUP II: Participants receive saline SC and undergo a sham fluoroscopy-guided SGB at baseline and optionally at 3 months. Participants also wear a hot flash monitor and actigraph watch for 6 months.
After completion of study treatment, participants are followed up at 3 and 6 months, and then optionally once a month for 6 months.
Trial Phase Phase II
Trial Type Treatment
- Primary ID NU 17B07
- Secondary IDs NCI-2017-01714, STU00204093
- Clinicaltrials.gov ID NCT03122301