Trial Outcomes & Findings for Effects of Stellate Ganglion Block on Hot Flashes in Hispanic Women With Breast Cancer (NCT NCT03122301)
NCT ID: NCT03122301
Last Updated: 2022-08-09
Results Overview
2 month subject reported daily hot flashes measured from day 60 to day 90 after treatment (mean value).
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
2 participants
Primary outcome timeframe
2 months after treatment
Results posted on
2022-08-09
Participant Flow
Participant milestones
| Measure |
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.
|
Saline
Saline injection
Saline: sham injection with saline
|
|---|---|---|
|
Overall Study
STARTED
|
1
|
1
|
|
Overall Study
COMPLETED
|
1
|
1
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effects of Stellate Ganglion Block on Hot Flashes in Hispanic Women With Breast Cancer
Baseline characteristics by cohort
| Measure |
Bupivicaine
n=1 Participants
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.
|
Saline
n=1 Participants
Saline injection
Saline: sham injection with saline
|
Total
n=2 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Age
|
48 years
n=99 Participants
|
36 years
n=107 Participants
|
42 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 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
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 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
|
|
Region of Enrollment
United States
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Baseline Hot Flashes
|
1.3 Number of hot flashes/night
STANDARD_DEVIATION 1.94 • n=99 Participants
|
4.58 Number of hot flashes/night
STANDARD_DEVIATION 2.78 • n=107 Participants
|
2.94 Number of hot flashes/night
STANDARD_DEVIATION 2.91 • n=206 Participants
|
PRIMARY outcome
Timeframe: 2 months after treatment2 month subject reported daily hot flashes measured from day 60 to day 90 after treatment (mean value).
Outcome measures
| Measure |
Bupivicaine
n=1 Participants
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.
|
Saline
n=1 Participants
Saline injection
Saline: sham injection with saline
|
|---|---|---|
|
2 Month Subject Reported Daily Hot Flashes (Mean)
|
.36 Number of hot flashes/night
Standard Deviation .37
|
4.13 Number of hot flashes/night
Standard Deviation 2.5
|
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place