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Effects of Stellate Ganglion Block on Hot Flashes in Hispanic Women With Breast Cancer

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ClinicalTrials.gov Identifier: NCT03122301
Recruitment Status : Recruiting
First Posted : April 20, 2017
Last Update Posted : September 7, 2018
Sponsor:
Collaborators:
Indiana University
University of Illinois at Chicago
Information provided by (Responsible Party):
David Walega, Northwestern University

Brief 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.

Condition or disease Intervention/treatment Phase
Hot Flashes Hot Flushes Vasomotor Symptoms Drug: Stellate Ganglion Block injection with bupivicaine Drug: Saline Phase 2

Detailed 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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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
Saline injection
Drug: Saline
sham injection with saline




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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



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Ages Eligible for Study:   30 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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,


Information from the National Library of Medicine

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


Contacts
Contact: Suzanne Banuvar, MPA, CCRC 312-695-7771 s-banuvar@northwestern.edu
Contact: Denise Romero 312-503-1804 dromero@nm.org

Locations
United States, Illinois
Anesthesiology Pain Medicine Center Recruiting
Chicago, Illinois, United States, 60605
Contact: Suzanne Banuvar    312-695-7771      
Sponsors and Collaborators
Northwestern University
Indiana University
University of Illinois at Chicago
Investigators
Principal Investigator: David R. Walega, MD, MSCI Northwestern University

Responsible Party: David Walega, Associate Professor of Anesthesiology, Northwestern University
ClinicalTrials.gov Identifier: NCT03122301     History of Changes
Other Study ID Numbers: STU00204093
First Posted: April 20, 2017    Key Record Dates
Last Update Posted: September 7, 2018
Last Verified: September 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Hot Flashes
Signs and Symptoms
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents