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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.


Recruitment information / eligibility

Status Terminated
Enrollment 2
Est. completion date July 1, 2020
Est. primary completion date July 1, 2020
Accepts healthy volunteers No
Gender Female
Age group 30 Years to 70 Years
Eligibility 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, -

Study Design


Related Conditions & MeSH terms


Intervention

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.
Saline
sham injection with saline

Locations

Country Name City State
United States Anesthesiology Pain Medicine Center Chicago Illinois

Sponsors (3)

Lead Sponsor Collaborator
Northwestern University Indiana University, University of Illinois at Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
See also
  Status Clinical Trial Phase
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Completed NCT05419908 - Trial to Investigate the Effect of ESN364 in Early Postmenopausal Women Suffering From Hot Flashes Phase 2
Completed NCT01281332 - Mechanical Device for the Relief of Hot Flashes Phase 2
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Completed NCT00755417 - Study of Gabapentin Extended Release (G-ER) in the Treatment of Vasomotor (Hot Flashes/Hot Flushes) Symptoms in Postmenopausal Women Phase 3
Completed NCT01293695 - Hypnosis For Hot Flashes Among Postmenopausal Women in a Randomized Clinical Trial N/A
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Completed NCT00256685 - Study Evaluating DVS-233 SR to Treat Vasomotor Systems Associated With Menopause Phase 3
Completed NCT00391417 - Efficacy and Safety of a Topical Estradiol Gel for Treatment of Postmenopausal Symptoms Phase 3
Terminated NCT00244894 - Acupuncture in Treating Hot Flashes in Patients With Prostate Cancer N/A
Completed NCT00010712 - Effects of Black Cohosh on Menopausal Hot Flashes Phase 2
Active, not recruiting NCT03580499 - Vitamin B6 in Reducing Hot Flashes in Participants With Prostate Cancer Undergoing Antiandrogen Therapy N/A
Recruiting NCT06030388 - Strength and Aerobic Training Against Hot Flushes in Postmenopausal Women N/A
Recruiting NCT04418115 - Fatigue as a Late Effect in Breast Cancer Survivors - is Acupuncture a Treatment Option? N/A
Recruiting NCT04861701 - Effect and Predictors for Hot Flush in Women Undergoing Static Stretching Exercise N/A
Active, not recruiting NCT05086705 - EMBr Wave for the Reduction of Hot Flashes in Women With a History of Breast Cancer N/A
Completed NCT05099159 - A Study to Learn More About How Well Elinzanetant Works and How Safe it is for the Treatment of Vasomotor Symptoms (Hot Flashes) That Are Caused by Hormonal Changes Over 26 Weeks in Women Who Have Been Through the Menopause (OASIS-2) Phase 3
Completed NCT01140646 - Evaluation of SAMe for Hot Flashes Phase 2