Hot Flashes Clinical Trial
Official title:
Effects of Stellate Ganglion Block on Hot Flashes in Hispanic Women With Breast Cancer: A Pilot Randomized Sham-Controlled Trial
Verified date | July 2022 |
Source | Northwestern University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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, - |
Country | Name | City | State |
---|---|---|---|
United States | Anesthesiology Pain Medicine Center | Chicago | Illinois |
Lead Sponsor | Collaborator |
---|---|
Northwestern University | Indiana University, University of Illinois at Chicago |
United States,
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT04587154 -
Womens Study to Alleviate Vasomotor Symptoms
|
N/A | |
Terminated |
NCT03642119 -
Validation of an Objective Instrument to Measure Hot Flashes During Menopause
|
||
Completed |
NCT05061563 -
A Study to Learn How a Proton Pump Inhibitor Affects the Way Elinzanetant (BAY 3427080) Moves Into, Through and Out of the Body, and How Much of it Gets Absorbed by the Body When Taken as a Single and Small Radioactive Dose in Healthy Adults
|
Phase 1 | |
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 | |
Completed |
NCT01439945 -
Magnesium Oxide in Treating Postmenopausal Women With Hot Flashes and a History of Breast Cancer
|
Phase 2 | |
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 | |
Completed |
NCT00599456 -
Investigation of the Usefulness of Omega 3 Vitamins in the Relief of Hot Flashes in Menopausal Women.
|
N/A | |
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 |