Trial Outcomes & Findings for Stellate Ganglion Block (SGB) For Women for Breast Cancer (NCT NCT02513329)
NCT ID: NCT02513329
Last Updated: 2023-06-05
Results Overview
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)
COMPLETED
PHASE2
37 participants
6 months after intervention
2023-06-05
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
17
|
|
Overall Study
COMPLETED
|
15
|
15
|
|
Overall Study
NOT COMPLETED
|
5
|
2
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
5
|
2
|
Baseline Characteristics
Stellate Ganglion Block (SGB) For Women for Breast Cancer
Baseline characteristics by cohort
| Measure |
Bupivicaine
n=20 Participants
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.
|
Saline
n=17 Participants
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.
|
Total
n=37 Participants
Total of all reporting groups
|
|---|---|---|---|
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CES D Depressive Symptoms
|
13 score on a scale (0 low-60 high)
STANDARD_DEVIATION 10.32 • n=99 Participants
|
13.38 score on a scale (0 low-60 high)
STANDARD_DEVIATION 12.6 • n=107 Participants
|
13.2 score on a scale (0 low-60 high)
STANDARD_DEVIATION 11.5 • n=206 Participants
|
|
Age, Continuous
|
51.5 Years
STANDARD_DEVIATION 7.79 • n=99 Participants
|
54.8 Years
STANDARD_DEVIATION 10.99 • n=107 Participants
|
53.1 Years
STANDARD_DEVIATION 9.3 • n=206 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
37 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
18 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
35 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
25 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=99 Participants
|
17 participants
n=107 Participants
|
37 participants
n=206 Participants
|
|
Body Mass Index (kg/m^2)
|
28.0 (kg/m^2)
STANDARD_DEVIATION 4.26 • n=99 Participants
|
32.84 (kg/m^2)
STANDARD_DEVIATION 6.32 • n=107 Participants
|
30.9 (kg/m^2)
STANDARD_DEVIATION 5.15 • n=206 Participants
|
|
Surgical menopause
|
4 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Post menopausal
|
16 count of participants
n=99 Participants
|
13 count of participants
n=107 Participants
|
29 count of participants
n=206 Participants
|
|
Pittsburgh Sleep Quality Index (PSQI)
|
14.43 score on a scale (0 good- 21 poor)
STANDARD_DEVIATION 4.58 • n=99 Participants
|
12.87 score on a scale (0 good- 21 poor)
STANDARD_DEVIATION 4.56 • n=107 Participants
|
13.75 score on a scale (0 good- 21 poor)
STANDARD_DEVIATION 4.57 • n=206 Participants
|
|
Functional Assessment of Cancer (FACT-B
|
98.09 score on a scale (0 poor- 123 good)
STANDARD_DEVIATION 24.21 • n=99 Participants
|
99.54 score on a scale (0 poor- 123 good)
STANDARD_DEVIATION 24.22 • n=107 Participants
|
98.71 score on a scale (0 poor- 123 good)
STANDARD_DEVIATION 24.21 • n=206 Participants
|
|
Vasomotor Symptoms (Hot Flash)
|
11.0 Number of hot flashes/day
STANDARD_DEVIATION 6.19 • n=99 Participants
|
8.78 Number of hot flashes/day
STANDARD_DEVIATION 3.09 • n=107 Participants
|
10.04 Number of hot flashes/day
STANDARD_DEVIATION 4.84 • n=206 Participants
|
|
Objective vasomotor symptoms (Hot Flashes)
|
15.74 Number of hot flashes/day
STANDARD_DEVIATION 11.22 • n=99 Participants
|
20.02 Number of hot flashes/day
STANDARD_DEVIATION 10.95 • n=107 Participants
|
17.59 Number of hot flashes/day
STANDARD_DEVIATION 11.10 • n=206 Participants
|
|
Intensity of hot flashes (diary)
|
33.67 score on a scale (0-100 most intensity)
STANDARD_DEVIATION 23.7 • n=99 Participants
|
27.38 score on a scale (0-100 most intensity)
STANDARD_DEVIATION 11.83 • n=107 Participants
|
30.94 score on a scale (0-100 most intensity)
STANDARD_DEVIATION 18.56 • n=206 Participants
|
PRIMARY outcome
Timeframe: 6 months after interventionPopulation: 3 subjects in the bupivicaine group data was not available, 2 subjects in the saline treatment group data was not available.
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)
Outcome measures
| Measure |
Bupivicaine
n=12 Participants
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.
|
Saline
n=13 Participants
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.
|
|---|---|---|
|
Change in Number of Night Sweats From Baseline to 6 Months After Intervention.
|
5.46 night sweats/month
Interval 0.0 to 117.0
|
10.09 night sweats/month
Interval 0.0 to 127.0
|
PRIMARY outcome
Timeframe: 6 months after interventionPopulation: 2 in the bupivicaine and 1 in the saline group at 6 months did not respond to interview.
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)
Outcome measures
| Measure |
Bupivicaine
n=13 Participants
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.
|
Saline
n=14 Participants
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.
|
|---|---|---|
|
Change in Number of Hot Flashes From Baseline to 6 Months After Intervention. [Time Frame: 6 Months After Intervention]
|
34.3 Hot flashes/month
Interval 6.0 to 298.0
|
172.62 Hot flashes/month
Interval 2.0 to 1887.0
|
PRIMARY outcome
Timeframe: 6 months after stellate ganglion block procedurePopulation: 10 subjects in the bupivicane group data not obtained and 4 subjects in the saline group not obtained at six 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.
Outcome measures
| Measure |
Bupivicaine
n=20 Participants
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.
|
Saline
n=17 Participants
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.
|
|---|---|---|
|
Intensity of Subjective Hot Flashes (HF) at Baseline and 6 Months
Hot Flash Intensity Baseline
|
411.4 score on a scale
Interval 151.0 to 1404.0
|
229.8 score on a scale
Interval 72.0 to 531.0
|
|
Intensity of Subjective Hot Flashes (HF) at Baseline and 6 Months
Hot Flash Intensity 6 Months
|
343.3 score on a scale
Interval 11.0 to 771.0
|
594.92 score on a scale
Interval 2.0 to 3774.0
|
SECONDARY outcome
Timeframe: 6 months following interventionPopulation: 5 subjects in the bupivicaine group and 2 subjects in the saline group data not available.
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
Outcome measures
| Measure |
Bupivicaine
n=15 Participants
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.
|
Saline
n=15 Participants
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.
|
|---|---|---|
|
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
|
1.16 Score on a scale
Standard Deviation 1.56
|
SECONDARY outcome
Timeframe: 6 month following interventionPopulation: 5 subjects in the bupivicaine group and 2 subject in the saline group data was not available.
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.
Outcome measures
| Measure |
Bupivicaine
n=15 Participants
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.
|
Saline
n=15 Participants
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.
|
|---|---|---|
|
Changes From Baseline of Pittsburg Sleep Quality Inventory (PSQI)
|
10.84 Score on a scale
Standard Deviation 1.14
|
11.92 Score on a scale
Standard Deviation 1.10
|
Adverse Events
Bupivicaine
Saline
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place