Clinical Trial Details
— Status: Terminated
Administrative data
NCT number |
NCT03122301 |
Other study ID # |
STU00204093 |
Secondary ID |
|
Status |
Terminated |
Phase |
Phase 2
|
First received |
|
Last updated |
|
Start date |
June 1, 2017 |
Est. completion date |
July 1, 2020 |
Study information
Verified date |
July 2022 |
Source |
Northwestern University |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial 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.
Description:
In this study, investigators aim to assess the effects of SGB on VMS, sympathetic nervous
system activity, depression and sleep in Hispanic and Spanish-Speaking women with breast
cancer on endocrine therapy who take tamoxifen, aromatase inhibitors (AIs) or SERMS, in a
prospective, randomized, sham-controlled pilot study.
Project Hypothesis: The frequency and intensity of subjective and objective VMS will be
significantly lower in women randomized to active SGB as compared to sham control.
Project Scope: Hispanic and Spanish-speaking women with breast cancer on tamoxifen, aromatase
inhibitors or SERMs with moderate to severe VMS will be enrolled as participants in this
study. Eligible women will be specifically recruited from the oncology practice of Dr. Cesar
Santa Maria, as well as Northwestern Memorial Hospital and other Northwestern affiliates.
Specific Goals and Objectives:
Goal 1: Determine the effect of stellate ganglion blockade (SGB) for reducing subjective and
objective VMS in Hispanic women with breast cancer on endocrine therapy as this population is
known to have a greater severity of VMS and has been notoriously underserved and understudied
in the U.S. and in clinical trials.
Goal 2: 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.
Goal 3: Evaluate the effect of SGB on mood, sleep, and quality of life in women with breast
cancer on tamoxifen, AIs, or SERMs.
Goal 4: Using the results of this pilot study, investigators plan to submit an R01 grant to
the National Cancer Institute in 2017 for a larger scale study.