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

NCT03122301 | Terminated Phase 2 Results FDA Drug

• 1 other identifier: STU00204093
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Hot Flashes; Hot Flushes; Vasomotor Symptoms

Outcome Measures

Primary Outcomes (1)

• 2 Month Subject Reported Daily Hot Flashes (Mean)

  2 month subject reported daily hot flashes measured from day 60 to day 90 after treatment (mean value).

  2 months after treatment

Study Arms (2)

Bupivicaine

ACTIVE COMPARATOR

Stellate Ganglion Block Injection with bupivicaine

Drug: Stellate Ganglion Block injection with bupivicaine

Saline

SHAM COMPARATOR

Saline injection

Drug: Saline

Interventions

Stellate Ganglion Block injection with bupivicaine DRUG

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.

Also known as: Marcaine

Bupivicaine

Saline DRUG

sham injection with saline

Saline

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Hispanic or Spanish speaking women aged 30 to 70 years
• 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 an SSRI,SNRI or membrane stabilizer (pregabalin, gabapentin, for example), it must be a stable, unchanged dose for previous 3 months

You may not qualify if:

• \. 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,

Sponsors & Collaborators

• Northwestern University: lead
• Indiana University: collaborator
• University of Illinois at Chicago: collaborator

Study Sites (1)

Anesthesiology Pain Medicine Center

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Hot Flashes

Interventions

Bupivacaine; Sodium Chloride

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Limitations and Caveats

This study was terminated due to low enrollment

Results Point of Contact

• Title: David Walega, MD
• Organization: Northwestern Medicine

d-walega@northwestern.edu

13129271345

Study Officials

• David R. Walega, MD, MSCI

  Northwestern University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Anesthesiology

Study Record Dates

• First Submitted: April 18, 2017
• First Posted: April 20, 2017
• Study Start: June 1, 2017
• Primary Completion: July 1, 2020
• Study Completion: July 1, 2020
• Last Updated: August 9, 2022
• Results First Posted: June 3, 2022

Record last verified: 2022-07

Locations

US (1)