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)

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

37 participants

Primary outcome timeframe

6 months after intervention

Results posted on

2023-06-05

Participant Flow

Participant milestones

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

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

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
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 intervention

Population: 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

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 intervention

Population: 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

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 procedure

Population: 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

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 intervention

Population: 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

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 intervention

Population: 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

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

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Saline

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Paul Fitzgerald

Northwestern University

Phone: 312-695-1064

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place