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| Name | Class |
|---|---|
| University of Illinois at Chicago | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bupivicaine | Active Comparator | Stellate Ganglion Block injection with 10 mL .5 % bupivacaine. |
|
| Saline | Sham Comparator | Saline injection (.9 normal saline) 5 ml. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bupivicaine | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 6 months after intervention |
| 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) | 6 months after intervention |
| 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. | 6 months after stellate ganglion block procedure |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David R. Walega, MD, MSCI | Northwestern University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern University Feinberg School of Medicine | Chicago | Illinois | 60611 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33110036 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. 10mL of 0.5% bupivicaine will be administered. |
| FG001 | 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. 5 mL of sterile normal saline will be administered. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Number of subjects who consented and randomized to treatment.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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) | 3 subjects in the bupivicaine group data was not available, 2 subjects in the saline treatment group data was not available. | Posted | Mean | Full Range | night sweats/month | 6 months after intervention |
|
7 days after the first stellate ganglion block.
Adverse events are collected up to 7 days after the stellate ganglion block procedure.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Paul Fitzgerald | Northwestern University | 312-695-1064 | p-fitzgerald2@northwestern.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 4, 2019 | Nov 4, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D019584 | Hot Flashes |
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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|
|
| Saline | Drug | 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. |
|
|
| 6 months following intervention |
| 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. | 6 month following intervention |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Body Mass Index (kg/m^2) | Mean | Standard Deviation | (kg/m^2) |
|
| Surgical menopause | Number of participants who have undergone a surgical procedure resulting in menopause. | Count of Participants | Participants | No |
|
| Post menopausal | Participants who are post menopausal | Number | count of participants |
|
| CES D Depressive Symptoms | CES D is a 20 question survey where each question is scored 0-3 for a possible score of 0 low possibility of depression to 60. A score of 16 on the survey indicates a possibility of depression. | Mean | Standard Deviation | score on a scale (0 low-60 high) |
|
| Pittsburgh Sleep Quality Index (PSQI) | The PSQI is a 7 component survey which is scored on a likert scale of 0 no disfunction to 3 great disfunction. A score of 0-21 is possible. A score of 21 would indicate worst sleep quality. | Mean | Standard Deviation | score on a scale (0 good- 21 poor) |
|
| Functional Assessment of Cancer (FACT-B | The Functional Assessment of Cancer is a 37 item questionnaire scored using a likert scale of 0 (not at all) - to 4 (very much). The score ranges from 0 (poor) to 123 (good). | Mean | Standard Deviation | score on a scale (0 poor- 123 good) |
|
| Vasomotor Symptoms (Hot Flash) | Vasomotor symptoms (hot flashes) number per day as recorded by the participant using a daily diary. | Mean | Standard Deviation | Number of hot flashes/day |
|
| Objective vasomotor symptoms (Hot Flashes) | Objective vasomotor hot flashes per day identified using a monitor attached non-invasively to paticipants skin. | Mean | Standard Deviation | Number of hot flashes/day |
|
| Intensity of hot flashes (diary) | Intensity of hot flashes reported by the participant in a daily diary. Scored on a scale of 0- no intensity to 100 greatest intensity. | Mean | Standard Deviation | score on a scale (0-100 most intensity) |
|
| OG001 | 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. |
|
|
| 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) | 2 in the bupivicaine and 1 in the saline group at 6 months did not respond to interview. | Posted | Mean | Full Range | Hot flashes/month | 6 months after intervention |
|
|
|
| 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. | 10 subjects in the bupivicane group data not obtained and 4 subjects in the saline group not obtained at six months. | Posted | Mean | Full Range | score on a scale | 6 months after stellate ganglion block procedure |
|
|
|
| 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 | 5 subjects in the bupivicaine group and 2 subjects in the saline group data not available. | Posted | Mean | Standard Deviation | Score on a scale | 6 months following intervention |
|
|
|
| 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. | 5 subjects in the bupivicaine group and 2 subject in the saline group data was not available. | Posted | Mean | Standard Deviation | Score on a scale | 6 month following intervention |
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|
|
| 0 |
| 20 |
| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | 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. | 0 | 17 | 0 | 17 | 0 | 17 |
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| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D000588 |
| Amines |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
| Hot Flash Intensity 6 Months |
|
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