Trial Outcomes & Findings for (SGB) in Men Treated for Prostate Cancer Improve Hot Flashes (NCT NCT03796195)
NCT ID: NCT03796195
Last Updated: 2023-01-25
Results Overview
Change in mean daily hot flashes using a self-report hot flash diary from baseline to 3 months after stellate ganglion block.
TERMINATED
PHASE4
1 participants
3 months after SGB procedure
2023-01-25
Participant Flow
Participant milestones
| Measure |
.5% Bupivacaine
Guided right sided stelate ganglion block using .5% bupivacaine (5mLs)
.5% Bupivacaine: Ultrasound guided right sided stelate ganglion block using .5% bupivacaine (5mLs)
|
|---|---|
|
Overall Study
STARTED
|
1
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
.5% Bupivacaine
Guided right sided stelate ganglion block using .5% bupivacaine (5mLs)
.5% Bupivacaine: Ultrasound guided right sided stelate ganglion block using .5% bupivacaine (5mLs)
|
|---|---|
|
Overall Study
Study closed early
|
1
|
Baseline Characteristics
(SGB) in Men Treated for Prostate Cancer Improve Hot Flashes
Baseline characteristics by cohort
| Measure |
.5% Bupivacaine
n=1 Participants
Guided right sided stelate ganglion block using .5% bupivacaine (5mLs)
.5% Bupivacaine: Ultrasound guided right sided stelate ganglion block using .5% bupivacaine (5mLs)
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=39 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=39 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=39 Participants
|
|
Age, Continuous
|
67 years
n=39 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=39 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=39 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=39 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
|
Region of Enrollment
United States
|
1 participants
n=39 Participants
|
|
Body Mass Index (kg/m^2)
|
25 (kg/m^2)
n=39 Participants
|
|
Baseline Hot Flash-Related Daily Interference Scale (HFRDIS)
|
48 score on a scale
n=39 Participants
|
|
Baseline mean daily hot flashes
|
9.78 Hot flashes/day
n=39 Participants
|
|
PROMIS SF4a Sleep Score
|
11 Score on a scale
n=39 Participants
|
PRIMARY outcome
Timeframe: 3 months after SGB procedureChange in mean daily hot flashes using a self-report hot flash diary from baseline to 3 months after stellate ganglion block.
Outcome measures
| Measure |
.5% Bupivacaine
n=1 Participants
Guided right sided stelate ganglion block using .5% bupivacaine (5mLs)
.5% Bupivacaine: Ultrasound guided right sided stelate ganglion block using .5% bupivacaine (5mLs)
|
|---|---|
|
Hot Flash Frequency Change Baseline to 3 Months After Treatment.
|
-1.78 Hot flashes/day
|
SECONDARY outcome
Timeframe: 3 months after stellate ganglion blockThe change in hot flash severity (hot flash frequency x hot flash intensity) between baseline and 3 months after SGB. Hot flash severity is determined using the mean frequency= ((Fmo+Fse))7 where FMi, Fmo and Fse are the weekly total number of mild, moderate or severe HF events. The mean severity= (Fmi+2x Fmo + 3 x Fse)/7 where FMI, Fmo and Fse are the weekly total number of mild, moderate or severe/very severe hot flash events in the case of mean severity, frequency of mild vasomotor symptoms is not counted at baseline.
Outcome measures
| Measure |
.5% Bupivacaine
n=1 Participants
Guided right sided stelate ganglion block using .5% bupivacaine (5mLs)
.5% Bupivacaine: Ultrasound guided right sided stelate ganglion block using .5% bupivacaine (5mLs)
|
|---|---|
|
Change in Hot Flash Severity Baseline to 3 Months After Stellate Ganglion Block
|
-55.94 Score on a scale
|
SECONDARY outcome
Timeframe: 4 weeks after stellate ganglion blockPROMIS SF4a (sleep) Patient Reportee Outcomes Measurement Information System. The PROMIS SF4a is a 4 item questionnaire that queries sleep duration, quality and interruption. This instrument accesses self reported perceptions of sleep quality, sleep depth and restoratoin associated with sleep. This includes perceived difficulties and concerns with getting to sleep or staying asleep, as well as perceptions of the adequacy and satisfaction with sleep. The 4 items are scored 1-5 where 1 is good quality and 5 is poor quality for a total score range of 4 (good quality) to 20 (poor quality).
Outcome measures
| Measure |
.5% Bupivacaine
n=1 Participants
Guided right sided stelate ganglion block using .5% bupivacaine (5mLs)
.5% Bupivacaine: Ultrasound guided right sided stelate ganglion block using .5% bupivacaine (5mLs)
|
|---|---|
|
PROMIS SF4a Score 4 Weeks After Stellate Ganglion Block.
|
8 Score on a scale
|
SECONDARY outcome
Timeframe: 4 weeks after stellate ganglion blockThe PGIC assesses the participants improvement in hot flashes from the time of the stellate ganglion block to 4 weeks after the procedure. The PGIC queries how much the hot flashes have improved on a scale of 1 (very much improved) to 7 (very much worse).
Outcome measures
| Measure |
.5% Bupivacaine
n=1 Participants
Guided right sided stelate ganglion block using .5% bupivacaine (5mLs)
.5% Bupivacaine: Ultrasound guided right sided stelate ganglion block using .5% bupivacaine (5mLs)
|
|---|---|
|
Patient Global Impression of Change Score (PGIC)
|
4 Score on a scale
|
Adverse Events
.5% Bupivacaine
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