Effects of Stellate Ganglion Block on Hot Flashes in Hispanic Women With Breast Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03122301|
Recruitment Status : Recruiting
First Posted : April 20, 2017
Last Update Posted : September 7, 2018
|Condition or disease||Intervention/treatment||Phase|
|Hot Flashes Hot Flushes Vasomotor Symptoms||Drug: Stellate Ganglion Block injection with bupivicaine Drug: Saline||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Care Provider)|
|Primary Purpose:||Supportive Care|
|Official Title:||Effects of Stellate Ganglion Block on Hot Flashes in Hispanic Women With Breast Cancer: A Pilot Randomized Sham-Controlled Trial|
|Actual Study Start Date :||June 1, 2017|
|Estimated Primary Completion Date :||May 1, 2019|
|Estimated Study Completion Date :||May 1, 2019|
Active Comparator: Bupivicaine
Stellate Ganglion Block Injection with bupivicaine
Drug: Stellate Ganglion Block injection with bupivicaine
A computer-generated 1:1 block randomization scheme will be used to assign participants to receive either a SGB with bupivacaine or a sham injection with saline. Randomization will be performed by the injectionist immediately before the injection procedure by opening an opaque envelope to reveal the participant number and group assignment printed on an index card.
Other Name: Marcaine
Sham Comparator: Saline
sham injection with saline
- Changes from baseline and intensity of subjective hot flashes (HF) [ Time Frame: Up to 24 weeks (6 months) following intervention ]Changes from baseline of paper diary (subjective) measures
- Changes from baseline of frequency of objective hot flashes [ Time Frame: Up to 24 weeks (6 months) following intervention ]Changes from baseline frequency of objective HFs over a 24 hour period using a validated skin conductance monitor at baseline, 12 weeks and 6 months
- Changes from baseline of actigraph measures of sleep [ Time Frame: Up to 24 weeks (6 months) following intervention ]Changes from baseline of actigraph measures of sleep over a 24 hour period at baseline, 12 weeks and 6 months using an actigraph watch
- Changes from baseline of Skin Sympathetic Nerve Activity (SKNA) [ Time Frame: Up to 4 weeks following intervention ]Changes of recordings of SKNA using an FDA-approved, specifically configured portable device (Biomaton ME6000) at baseline, during, 2 and 4 weeks following intervention
- Composite changes from baseline of scores of measures of Quality of Life [ Time Frame: Up to 24 weeks (6 months) following intervention ]Composite changes from baseline to include: HFRDIS, FACT B, Post-injection questionnaire, Patient's Global Impression of Change (PGIC) at baseline, 3 and 6 months following intervention
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03122301
|Contact: Suzanne Banuvar, MPA, CCRCfirstname.lastname@example.org|
|Contact: Denise Romeroemail@example.com|
|United States, Illinois|
|Anesthesiology Pain Medicine Center||Recruiting|
|Chicago, Illinois, United States, 60605|
|Contact: Suzanne Banuvar 312-695-7771|
|Principal Investigator:||David R. Walega, MD, MSCI||Northwestern University|