Hot Flushes, Hot Flashes
Conditions
Keywords
Breast Cancer, Anti-estrogens, Hot Flushes, Tamoxifen, Aromatase inhibitors, Hot Flashes
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.
Interventions
DRUGBupivicaine
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.
DRUGSaline
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.
Sponsors
University of Illinois at Chicago
Northwestern University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Caregiver)
Eligibility
Sex/Gender
FEMALE
Age
30 Years to 70 Years
Healthy volunteers
No
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.)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Number of Night Sweats From Baseline to 6 Months After Intervention. | 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] | 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 | 6 months after stellate ganglion block procedure | 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
| Measure | Time frame | Description |
|---|---|---|
| Survey Score Changes From Baseline to 6 Months After Intervention Using the Epidemiological Studies-Depression(CES-D) Survey. | 6 months following intervention | 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) | 6 month following intervention | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Bupivicaine Stellate Ganglion Block injection with bupivacaine
Bupivicaine: 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. | 20 |
| Saline Saline injection
Saline: 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. | 17 |
| Total | 37 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 5 | 2 |
Baseline characteristics
| Characteristic | Bupivicaine | Saline | Total |
|---|---|---|---|
| Age, Continuous | 51.5 Years STANDARD_DEVIATION 7.79 | 54.8 Years STANDARD_DEVIATION 10.99 | 53.1 Years STANDARD_DEVIATION 9.3 |
| Body Mass Index (kg/m^2) | 28.0 (kg/m^2) STANDARD_DEVIATION 4.26 | 32.84 (kg/m^2) STANDARD_DEVIATION 6.32 | 30.9 (kg/m^2) STANDARD_DEVIATION 5.15 |
| CES D Depressive Symptoms | 13 score on a scale (0 low-60 high) STANDARD_DEVIATION 10.32 | 13.38 score on a scale (0 low-60 high) STANDARD_DEVIATION 12.6 | 13.2 score on a scale (0 low-60 high) STANDARD_DEVIATION 11.5 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 0 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 18 Participants | 17 Participants | 35 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Functional Assessment of Cancer (FACT-B | 98.09 score on a scale (0 poor- 123 good) STANDARD_DEVIATION 24.21 | 99.54 score on a scale (0 poor- 123 good) STANDARD_DEVIATION 24.22 | 98.71 score on a scale (0 poor- 123 good) STANDARD_DEVIATION 24.21 |
| Intensity of hot flashes (diary) | 33.67 score on a scale (0-100 most intensity) STANDARD_DEVIATION 23.7 | 27.38 score on a scale (0-100 most intensity) STANDARD_DEVIATION 11.83 | 30.94 score on a scale (0-100 most intensity) STANDARD_DEVIATION 18.56 |
| Objective vasomotor symptoms (Hot Flashes) | 15.74 Number of hot flashes/day STANDARD_DEVIATION 11.22 | 20.02 Number of hot flashes/day STANDARD_DEVIATION 10.95 | 17.59 Number of hot flashes/day STANDARD_DEVIATION 11.1 |
| Pittsburgh Sleep Quality Index (PSQI) | 14.43 score on a scale (0 good- 21 poor) STANDARD_DEVIATION 4.58 | 12.87 score on a scale (0 good- 21 poor) STANDARD_DEVIATION 4.56 | 13.75 score on a scale (0 good- 21 poor) STANDARD_DEVIATION 4.57 |
| Post menopausal | 16 count of participants | 13 count of participants | 29 count of participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 5 Participants | 9 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 14 Participants | 11 Participants | 25 Participants |
| Region of Enrollment United States | 20 participants | 17 participants | 37 participants |
| Sex: Female, Male Female | 20 Participants | 17 Participants | 37 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
| Surgical menopause | 4 Participants | 3 Participants | 7 Participants |
| Vasomotor Symptoms (Hot Flash) | 11.0 Number of hot flashes/day STANDARD_DEVIATION 6.19 | 8.78 Number of hot flashes/day STANDARD_DEVIATION 3.09 | 10.04 Number of hot flashes/day STANDARD_DEVIATION 4.84 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 17 |
| other Total, other adverse events | 0 / 20 | 0 / 17 |
| serious Total, serious adverse events | 0 / 20 | 0 / 17 |
Outcome results
Primary
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)
Time frame: 6 months after intervention
Population: 2 in the bupivicaine and 1 in the saline group at 6 months did not respond to interview.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Bupivicaine | Change in Number of Hot Flashes From Baseline to 6 Months After Intervention. [Time Frame: 6 Months After Intervention] | 34.3 Hot flashes/month |
| Saline | Change in Number of Hot Flashes From Baseline to 6 Months After Intervention. [Time Frame: 6 Months After Intervention] | 172.62 Hot flashes/month |
Primary
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)
Time frame: 6 months after intervention
Population: 3 subjects in the bupivicaine group data was not available, 2 subjects in the saline treatment group data was not available.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Bupivicaine | Change in Number of Night Sweats From Baseline to 6 Months After Intervention. | 5.46 night sweats/month |
| Saline | Change in Number of Night Sweats From Baseline to 6 Months After Intervention. | 10.09 night sweats/month |
Primary
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.
Time frame: 6 months after stellate ganglion block procedure
Population: 10 subjects in the bupivicane group data not obtained and 4 subjects in the saline group not obtained at six months.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Bupivicaine | Intensity of Subjective Hot Flashes (HF) at Baseline and 6 Months | Hot Flash Intensity Baseline | 411.4 score on a scale |
| Bupivicaine | Intensity of Subjective Hot Flashes (HF) at Baseline and 6 Months | Hot Flash Intensity 6 Months | 343.3 score on a scale |
| Saline | Intensity of Subjective Hot Flashes (HF) at Baseline and 6 Months | Hot Flash Intensity Baseline | 229.8 score on a scale |
| Saline | Intensity of Subjective Hot Flashes (HF) at Baseline and 6 Months | Hot Flash Intensity 6 Months | 594.92 score on a scale |
Secondary
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.
Time frame: 6 month following intervention
Population: 5 subjects in the bupivicaine group and 2 subject in the saline group data was not available.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bupivicaine | Changes From Baseline of Pittsburg Sleep Quality Inventory (PSQI) | 10.84 Score on a scale | Standard Deviation 1.14 |
| Saline | Changes From Baseline of Pittsburg Sleep Quality Inventory (PSQI) | 11.92 Score on a scale | Standard Deviation 1.1 |
Secondary
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
Time frame: 6 months following intervention
Population: 5 subjects in the bupivicaine group and 2 subjects in the saline group data not available.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bupivicaine | Survey Score Changes From Baseline to 6 Months After Intervention Using the Epidemiological Studies-Depression(CES-D) Survey. | -.14 Score on a scale | Standard Deviation 1.14 |
| Saline | Survey Score Changes From Baseline to 6 Months After Intervention Using the Epidemiological Studies-Depression(CES-D) Survey. | 1.16 Score on a scale | Standard Deviation 1.56 |