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=5 Participants	36 years n=7 Participants	42 years n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Baseline Hot Flashes	1.3 Number of hot flashes/night STANDARD_DEVIATION 1.94 • n=5 Participants	4.58 Number of hot flashes/night STANDARD_DEVIATION 2.78 • n=7 Participants	2.94 Number of hot flashes/night STANDARD_DEVIATION 2.91 • n=5 Participants

PRIMARY outcome

Timeframe: 2 months after treatment

2 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

David Walega, MD

Northwestern Medicine

Phone: 13129271345

Email: d-walega@northwestern.edu

Results disclosure agreements

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