Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
Study hypothesis
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
Ethics approval received from the Alexian Brothers Hospital Network Institutional Review Board on the 5th October 2006.
Study design
Interventional, single-centre, single arm, non-placebo controlled trial
Primary study design
Interventional
Secondary study design
Non randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
Primary outcome measures
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.
Secondary outcome measures
No secondary outcome measures
Overall trial start date
01/01/2007
Overall trial end date
01/01/2008
Reason abandoned
Eligibility
Participant inclusion criteria
1. 30 - 70 year old female breast cancer survivors
2. American Society of Anaesthesiologists (ASA) scores 3 or below
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
13
Participant exclusion criteria
Does not comply with the above inclusion criteria.
Recruitment start date
01/01/2007
Recruitment end date
01/01/2008
Locations
Countries of recruitment
United States of America
Trial participating centre
2260 W. Higgins Rd.
Hoffman Estates
60195
United States of America
Sponsor information
Organisation
Advanced Pain Centers (USA)
Sponsor details
2260 W. Higgins Rd.
Ste 101
Hoffman Estates
60195
United States of America
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Other
Funder name
Investigator initiated and funded (USA)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
Results in http://www.ncbi.nlm.nih.gov/pubmed/18485819
Publication citations
-
Results
Lipov EG, Joshi JR, Sanders S, Wilcox K, Lipov S, Xie H, Maganini R, Slavin K, Effects of stellate-ganglion block on hot flushes and night awakenings in survivors of breast cancer: a pilot study., Lancet Oncol., 2008, 9, 6, 523-532, doi: 10.1016/S1470-2045(08)70131-1.