Back to resultsStellate Ganglion Block (SGB) For Women for Breast Cancer
Primary Purpose
Hot Flushes, Hot Flashes
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Bupivicaine
Saline
Sponsored by
About this trial
This is an interventional supportive care trial for Hot Flushes focused on measuring Breast Cancer, Anti-estrogens, Hot Flushes, Tamoxifen, Aromatase inhibitors, Hot Flashes
Eligibility Criteria
Inclusion Criteria:
- aged 30 to 70 years
- 28 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.
- Approval of healthcare provider if ≥ 21 for depression and ≥15 for anxiety on the Depression Anxiety and Stress Scale (DASS)
- Stable use of Selective Serotonin Reuptake Inhibitors (SSRIs), Selective Norepinephrine Reuptake Inhibitors (SNRIs) if applicable
Exclusion Criteria:
- 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);
- 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,
- 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
- Mini-Mental State Exam (MMSE) ≥ 28
- conditions that can affect sleep quality (e.g., use of sleep agents; shift work; etc.)
Sites / Locations
- Northwestern University Feinberg School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Sham Comparator
Arm Label
Bupivicaine
Saline
Arm Description
Stellate Ganglion Block injection with 10 mL .5 % bupivacaine.
Saline injection (.9 normal saline) 5 ml.
Outcomes
Primary Outcome Measures
Change in Number of Night Sweats From Baseline to 6 Months After Intervention.
Change in number of mean night sweats from baseline to 6 months after intervention using a paper diary (subjective measure of frequency). Number is the change from mean baseline number of night sweats to mean 6 months after procedure (number of ns/month)
Change in Number of Hot Flashes From Baseline to 6 Months After Intervention. [Time Frame: 6 Months After Intervention]
Mean change in number of hot flashes from baseline to 6 months after intervention using a paper diary (subjective measure of frequency). Number is the change from mean baseline number of hot flashes to mean 6 months after procedure (number of ns/month)
Intensity of Subjective Hot Flashes (HF) at Baseline and 6 Months
Hot flashes intensity from baseline and at 6 months as reported by the subject using paper diary (subjective) measures of intensity (including mild, severe and very severe HF).Intensity scoring = Frequency*Severity = [(frequency of mild*1)+(frequency of moderate*2) + (frequency of severe*3) + (frequency of very severe*4)].
Mean intensity of hot flashes at baseline and 6 months. Score on a unlimited scale of 0- infinity based on number of hot flashes. A score on the scale where 0 is good higher scores are worse.
Secondary Outcome Measures
Survey Score Changes From Baseline to 6 Months After Intervention Using the Epidemiological Studies-Depression(CES-D) Survey.
Baseline score change compared to the 6 month survey score using the Epidemiological Studies-Depression(CES-D) survey. This survey is a 20-item measure that asks to rate how often over the past week they experienced symptoms associated with depression, such as restless sleep, poor appetite, and feeling lonely. Response options range from 0 to 3 for each item (0 = Rarely or None of the Time, 1 = Some or Little of the Time, 2 = Moderately or Much of the time, 3 = Most or Almost All the Time). Scores range from 0 to 60, with high scores indicating greater depressive symptoms. CES-D also provides cutoff scores (e.g., 16 or greater) that aid in identifying individuals at risk for clinical depression
Changes From Baseline of Pittsburg Sleep Quality Inventory (PSQI)
Change in Pittsburg Sleep Quality Inventory (PSQI) between baseline and 6 months post intervention. In scoring the PSQI, seven component scores are derived, each scored 0 (no difficulty) to 3 (severe difficulty). The component scores are summed to produce a global score (range 0 to 21). Higher scores indicate worse sleep quality.
Full Information
NCT ID
NCT02513329
First Posted
July 20, 2015
Last Updated
June 1, 2023
Sponsor
Northwestern University
Collaborators
University of Illinois at Chicago
1. Study Identification
Unique Protocol Identification Number
NCT02513329
Brief Title
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
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
July 2015 (Actual)
Primary Completion Date
January 2020 (Actual)
Study Completion Date
January 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University
Collaborators
University of Illinois at Chicago
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hot Flushes, Hot Flashes
Keywords
Breast Cancer, Anti-estrogens, Hot Flushes, Tamoxifen, Aromatase inhibitors, Hot Flashes
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
37 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Bupivicaine
Arm Type
Active Comparator
Arm Description
Stellate Ganglion Block injection with 10 mL .5 % bupivacaine.
Arm Title
Saline
Arm Type
Sham Comparator
Arm Description
Saline injection (.9 normal saline) 5 ml.
Intervention Type
Drug
Intervention Name(s)
Bupivicaine
Other Intervention Name(s)
Marcaine
Intervention Description
A computer-generated 1:1 block randomization scheme will be used to assign participants to receive bupivacaine. 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.10 mL .5% bupivicaine will be administered.
Intervention Type
Drug
Intervention Name(s)
Saline
Other Intervention Name(s)
Sodium chloride solution
Intervention Description
A computer-generated 1:1 block randomization scheme will be used to assign participants to receive 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. 5 mL sterile normal saline will be administered.
Primary Outcome Measure Information:
Title
Change in Number of Night Sweats From Baseline to 6 Months After Intervention.
Description
Change in number of mean night sweats from baseline to 6 months after intervention using a paper diary (subjective measure of frequency). Number is the change from mean baseline number of night sweats to mean 6 months after procedure (number of ns/month)
Time Frame
6 months after intervention
Title
Change in Number of Hot Flashes From Baseline to 6 Months After Intervention. [Time Frame: 6 Months After Intervention]
Description
Mean change in number of hot flashes from baseline to 6 months after intervention using a paper diary (subjective measure of frequency). Number is the change from mean baseline number of hot flashes to mean 6 months after procedure (number of ns/month)
Time Frame
6 months after intervention
Title
Intensity of Subjective Hot Flashes (HF) at Baseline and 6 Months
Description
Hot flashes intensity from baseline and at 6 months as reported by the subject using paper diary (subjective) measures of intensity (including mild, severe and very severe HF).Intensity scoring = Frequency*Severity = [(frequency of mild*1)+(frequency of moderate*2) + (frequency of severe*3) + (frequency of very severe*4)].
Mean intensity of hot flashes at baseline and 6 months. Score on a unlimited scale of 0- infinity based on number of hot flashes. A score on the scale where 0 is good higher scores are worse.
Time Frame
6 months after stellate ganglion block procedure
Secondary Outcome Measure Information:
Title
Survey Score Changes From Baseline to 6 Months After Intervention Using the Epidemiological Studies-Depression(CES-D) Survey.
Description
Baseline score change compared to the 6 month survey score using the Epidemiological Studies-Depression(CES-D) survey. This survey is a 20-item measure that asks to rate how often over the past week they experienced symptoms associated with depression, such as restless sleep, poor appetite, and feeling lonely. Response options range from 0 to 3 for each item (0 = Rarely or None of the Time, 1 = Some or Little of the Time, 2 = Moderately or Much of the time, 3 = Most or Almost All the Time). Scores range from 0 to 60, with high scores indicating greater depressive symptoms. CES-D also provides cutoff scores (e.g., 16 or greater) that aid in identifying individuals at risk for clinical depression
Time Frame
6 months following intervention
Title
Changes From Baseline of Pittsburg Sleep Quality Inventory (PSQI)
Description
Change in Pittsburg Sleep Quality Inventory (PSQI) between baseline and 6 months post intervention. In scoring the PSQI, seven component scores are derived, each scored 0 (no difficulty) to 3 (severe difficulty). The component scores are summed to produce a global score (range 0 to 21). Higher scores indicate worse sleep quality.
Time Frame
6 month following intervention
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
aged 30 to 70 years
28 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.
Approval of healthcare provider if ≥ 21 for depression and ≥15 for anxiety on the Depression Anxiety and Stress Scale (DASS)
Stable use of Selective Serotonin Reuptake Inhibitors (SSRIs), Selective Norepinephrine Reuptake Inhibitors (SNRIs) if applicable
Exclusion Criteria:
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);
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,
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
Mini-Mental State Exam (MMSE) ≥ 28
conditions that can affect sleep quality (e.g., use of sleep agents; shift work; etc.)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David R. Walega, MD, MSCI
Organizational Affiliation
Northwestern University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northwestern University Feinberg School of Medicine
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
33110036
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.
Results Reference
derived
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Stellate Ganglion Block (SGB) For Women for Breast Cancer
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