Clinical trial NCT02513329: Stellate Ganglion Block (SGB) For Women for Breast Cancer
Official title: Effects of Stellate Ganglion Block (SGB) on Vasomotor Symptoms in Women Receiving Anti-Estrogen Therapy for Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hot Flushes
Hot Flashes
Keywords: Breast Cancer
Anti-estrogens
Hot Flushes
Tamoxifen
Aromatase inhibitors
Hot Flashes
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: University of Illinois at Chicago
First posted: 2015-07-31
Enrollment: 37
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. 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. Approval of healthcare provider if ≥ 21 for depression and ≥15 for anxiety on the Depression Anxiety and Stress Scale (DASS)
7. Stable use of Selective Serotonin Reuptake Inhibitors (SSRIs), Selective Norepinephrine Reuptake Inhibitors (SNRIs) if applicable

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);
2. use of treatments in the past two months that can affect VMS (e.g., use of oral or transdermal Hormone Treatment (HT) or contraceptives, SERMS,
3. conditions or disorders that can affect performance on cognitive tests (e.g., dementia/mild cognitive impairment; stroke; traumatic brain injury; alcohol/substance use; inability to write, speak, or read in English, English as a second language
4. Mini-Mental State Exam (MMSE) ≥ 28
5. conditions that can affect sleep quality (e.g., use of sleep agents; shift work; etc.)

Primary outcomes:
measure: Change in Number of Night Sweats From Baseline to 6 Months After Intervention.
timeFrame: 6 months after intervention
measure: Change in Number of Hot Flashes From Baseline to 6 Months After Intervention. [Time Frame: 6 Months After Intervention]
timeFrame: 6 months after intervention
measure: Intensity of Subjective Hot Flashes (HF) at Baseline and 6 Months
timeFrame: 6 months after stellate ganglion block procedure
Secondary outcomes:
measure: Survey Score Changes From Baseline to 6 Months After Intervention Using the Epidemiological Studies-Depression(CES-D) Survey.
timeFrame: 6 months following intervention
measure: Changes From Baseline of Pittsburg Sleep Quality Inventory (PSQI)
timeFrame: 6 month following intervention
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University Feinberg School of Medicine
state: Illinois
Study officials:
affiliation: Northwestern University
name: David R. Walega, MD, MSCI
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fogel J, Rubin LH, Kilic E, Walega DR, Maki PM. Physiologic vasomotor symptoms are associated with verbal memory dysfunction in breast cancer survivors. Menopause. 2020 Nov;27(11):1209-1219. doi: 10.1097/GME.0000000000001608.