This phase II trial studies how well a stellate ganglion blockade with bupivacaine hydrochloride works in reducing hot flashes in Hispanic patients with breast cancer. A stellate ganglion blockade using bupivacaine hydrochloride (a local anesthetic used to block signals at nerve endings) may help to reduce the number and severity of hot flashes in Hispanic patients with breast cancer.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03122301.
PRIMARY OBJECTIVES:
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.
Lead OrganizationNorthwestern University
Principal InvestigatorDavid Walega
