Hot Flashes, Hot Flushes, Vasomotor Symptoms
Conditions
Brief summary
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.
Detailed description
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.
Interventions
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.
DRUGSaline
sham injection with saline
Sponsors
Indiana University
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. Hispanic or Spanish speaking women 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. if participant is on an SSRI,SNRI or membrane stabilizer (pregabalin, gabapentin, for example), it must be a stable, unchanged dose for previous 3 months
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, \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 2 Month Subject Reported Daily Hot Flashes (Mean) | 2 months after treatment | 2 month subject reported daily hot flashes measured from day 60 to day 90 after treatment (mean value). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 1 |
| Saline Saline injection
Saline: sham injection with saline | 1 |
| Total | 2 |
Baseline characteristics
| Characteristic | Bupivicaine | Saline | Total |
|---|---|---|---|
| Age, Customized Age | 48 years | 36 years | 42 years |
| Baseline Hot Flashes | 1.3 Number of hot flashes/night STANDARD_DEVIATION 1.94 | 4.58 Number of hot flashes/night STANDARD_DEVIATION 2.78 | 2.94 Number of hot flashes/night STANDARD_DEVIATION 2.91 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 1 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 1 Participants | 1 Participants | 2 Participants |
| Sex: Female, Male Female | 1 Participants | 1 Participants | 2 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 1 | 0 / 1 |
| other Total, other adverse events | 0 / 1 | 0 / 1 |
| serious Total, serious adverse events | 0 / 1 | 0 / 1 |
Outcome results
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).
Time frame: 2 months after treatment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bupivicaine | 2 Month Subject Reported Daily Hot Flashes (Mean) | .36 Number of hot flashes/night | Standard Deviation 0.37 |
| Saline | 2 Month Subject Reported Daily Hot Flashes (Mean) | 4.13 Number of hot flashes/night | Standard Deviation 2.5 |