Stellate ganglion block reduces hot flushes and night awakenings in breast cancer survivors: a pilot study

ISRCTN	ISRCTN14318565
DOI	https://doi.org/10.1186/ISRCTN14318565
Protocol serial number	N/A
Sponsor	Advanced Pain Centers (USA)
Funder	Investigator initiated and funded (USA)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Eugene Lipov
Scientific

2260 W. Higgins Rd.
Ste. 101
Hoffman Estates
60195
United States of America

Primary study design	Interventional
Study design	Interventional, single-centre, single arm, non-placebo controlled trial
Secondary study design	Non randomised controlled trial
Scientific title
Study objectives	The hypothesis is that stellate ganglion block decreases hot flushes and night awakenings in breast cancer survivors. The current project is to prove that hypothesis.
Ethics approval(s)	Ethics approval received from the Alexian Brothers Hospital Network Institutional Review Board on the 5th October 2006.
Health condition(s) or problem(s) studied	Hot flushes, night awakenings
Intervention	The intervention used was a stellate ganglion block at C6. Each patient had 1 - 2 blocks depending on the patient. Follow up was from before treatment to 12 weeks post-initial treatment. Observed occurrences were documented before and after intervention.
Intervention type	Other
Primary outcome measure(s)	1. Hot flush qualitative scores - mild to very severe 2. Quantitative hot flush occurrences per day 3. Night awakening per night Data was collected before the intervention and daily after the intervention for 12 weeks.
Key secondary outcome measure(s)	No secondary outcome measures
Completion date	01/01/2008

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target sample size at registration	13
Key inclusion criteria	1. 30 - 70 year old female breast cancer survivors 2. American Society of Anaesthesiologists (ASA) scores 3 or below
Key exclusion criteria	Does not comply with the above inclusion criteria.
Date of first enrolment	01/01/2007
Date of final enrolment	01/01/2008

2260 W. Higgins Rd.

Hoffman Estates
60195
United States of America

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	Results	01/06/2008		Yes	No