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Study stopped due to inadequate enrollment.
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| Name | Class |
|---|---|
| Indiana University | OTHER |
| University of Illinois at Chicago | OTHER |
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Vasomotor symptoms (hot flashes, night sweats, VMS) affect up to 65% of breast cancer survivors and negatively impact their quality of life. VMS in Hispanic women are significantly more severe as compared to non-Hispanic Caucasian women. Few effective treatments for VMS are available, especially in the underserved Hispanic and Spanish-speaking populations which is problematic, as Hispanics will comprise 20% of the U.S. population by 2025. Stellate ganglion nerve block (SGB) with local anesthetic, previously performed for chronic pain indications, has shown promise as a potential treatment for menopausal women with VMS in previous clinical trials, but has not been investigated in Hispanic or Spanish-Speaking women with breast cancer in a controlled study.
In this study, investigators aim to assess the effects of SGB on VMS, sympathetic nervous system activity, depression and sleep in Hispanic and Spanish-Speaking women with breast cancer on endocrine therapy who take tamoxifen, aromatase inhibitors (AIs) or SERMS, in a prospective, randomized, sham-controlled pilot study.
Project Hypothesis: The frequency and intensity of subjective and objective VMS will be significantly lower in women randomized to active SGB as compared to sham control.
Project Scope: Hispanic and Spanish-speaking women with breast cancer on tamoxifen, aromatase inhibitors or SERMs with moderate to severe VMS will be enrolled as participants in this study. Eligible women will be specifically recruited from the oncology practice of Dr. Cesar Santa Maria, as well as Northwestern Memorial Hospital and other Northwestern affiliates.
Specific Goals and Objectives:
Goal 1: Determine the effect of stellate ganglion blockade (SGB) for reducing subjective and objective VMS in Hispanic women with breast cancer on endocrine therapy as this population is known to have a greater severity of VMS and has been notoriously underserved and understudied in the U.S. and in clinical trials.
Goal 2: Evaluate the effect of SGB on the sympathetic nervous system over time to gain new knowledge on the physiologic mechanism of SGB effects on VMS.
Goal 3: Evaluate the effect of SGB on mood, sleep, and quality of life in women with breast cancer on tamoxifen, AIs, or SERMs.
Goal 4: Using the results of this pilot study, investigators plan to submit an R01 grant to the National Cancer Institute in 2017 for a larger scale study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bupivicaine | Active Comparator | Stellate Ganglion Block Injection with bupivicaine |
|
| Saline | Sham Comparator | Saline injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stellate Ganglion Block injection with bupivicaine | Drug | A computer-generated 1:1 block randomization scheme will be used to assign participants to receive either a SGB with bupivacaine or a sham injection with 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 2 Month Subject Reported Daily Hot Flashes (Mean) | 2 month subject reported daily hot flashes measured from day 60 to day 90 after treatment (mean value). | 2 months after treatment |
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Inclusion Criteria:
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); pregnancy 2. use of treatments in the past 2 months that can affect VMS (e.g., use of oral or transdermal HT or contraceptives,
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| Name | Affiliation | Role |
|---|---|---|
| David R. Walega, MD, MSCI | Northwestern University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anesthesiology Pain Medicine Center | Chicago | Illinois | 60611 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Bupivicaine | Stellate Ganglion Block Injection with bupivicaine Stellate Ganglion Block injection with bupivicaine: A computer-generated 1:1 block randomization scheme will be used to assign participants to receive either a SGB with bupivacaine or a sham injection with 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. |
| FG001 | Saline | Saline injection Saline: sham injection with saline |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Bupivicaine | Stellate Ganglion Block Injection with bupivicaine Stellate Ganglion Block injection with bupivicaine: A computer-generated 1:1 block randomization scheme will be used to assign participants to receive either a SGB with bupivacaine or a sham injection with 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | 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 | 2 Month Subject Reported Daily Hot Flashes (Mean) | 2 month subject reported daily hot flashes measured from day 60 to day 90 after treatment (mean value). | Posted | Mean | Standard Deviation | Number of hot flashes/night | 2 months after treatment |
|
6 months
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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 bupivicaine Stellate Ganglion Block injection with bupivicaine: A computer-generated 1:1 block randomization scheme will be used to assign participants to receive either a SGB with bupivacaine or a sham injection with 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. |
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This study was terminated due to low enrollment
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| David Walega, MD | Northwestern Medicine | 13129271345 | d-walega@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 | Jan 5, 2017 | Apr 6, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D019584 | Hot Flashes |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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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 | sham injection with saline |
|
| BG001 | Saline | Saline injection Saline: sham injection with saline |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Baseline Hot Flashes | Mean number of hot flashes per night for one month before treatment as reported by the study participant. | Mean | Standard Deviation | Number of hot flashes/night |
|
Saline injection Saline: sham injection with saline |
|
|
| 0 |
| 1 |
| 0 |
| 1 |
| 0 |
| 1 |
| EG001 | Saline | Saline injection Saline: sham injection with saline | 0 | 1 | 0 | 1 | 0 | 1 |
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| D000588 |
| Amines |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |