Hot Flashes Clinical Trial
Official title:
Effects of Stellate Ganglion Block (SGB) on Vasomotor Symptoms in Women Receiving Anti-Estrogen Therapy for Breast Cancer
Vasomotor symptoms (VMS) affect up to 65% of breast cancer survivors and negatively impact their quality of life. The investigators aim to evaluate the benefit of SGB in symptomatic women with breast cancer who are on anti-estrogens and are seeking relief from moderate to very severe VMS that are adversely affecting health and wellbeing. Women with breast cancer on Tamoxifen, aromatase inhibitors (AIs) or Selective Estrogen Receptor Modulators (SERMS) with moderate to very severe VMS will be enrolled as participants in this study.
Hypotheses: The frequency and intensity of subjective and objective VMS will be significantly lower in women randomized to active SGB as compared to sham controls. Mood, memory, cognition, sleep, and quality of life will all be improved in the treatment group as compared to the sham-control group. Specific Goals and Objectives: Goal 1: To determine the effect of stellate ganglion blockade (SGB) for reducing subjective and objective VMS in women with breast cancer on tamoxifen, AIs, or SERMs Goal 2: To evaluate the effect of SGB on mood, memory, cognition, sleep and quality of life in women with breast cancer on tamoxifen, AIs, or SERMs. We aim to conduct a randomized, single-site, sham-control clinical trial of SGB on VMS in 30 women with breast cancer on anti-estrogen therapy (15 per group). The primary entry criterion will be 28 or more moderate to very severe hot flashes per week. VMS will be measured by self-report on a written daily dairy over a 6-month period. Secondary outcomes include changes in mood, sleep, quality of life, and objective hot flashes measured by ambulatory monitoring (skin-conductance temperature monitoring) for 24 hours at baseline, three months and six months. Memory performance with neurocognitive testing will be done at baseline and 3 months. ;
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 |