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Stellate ganglion block reduces hot flushes and night awakenings in breast cancer survivors: a pilot study
ISRCTN ISRCTN14318565
DOI 10.1186/ISRCTN14318565
ClinicalTrials.gov identifier
EudraCT number
Public title Stellate ganglion block reduces hot flushes and night awakenings in breast cancer survivors: a pilot study
Scientific title
Acronym N/A
Serial number at source N/A
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.
Lay summary
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
Countries of recruitment United States of America
Disease/condition/study domain Hot flushes, night awakenings
Participants - inclusion criteria 1. 30 - 70 year old female breast cancer survivors
2. American Society of Anaesthesiologists (ASA) scores 3 or below
Participants - exclusion criteria Does not comply with the above inclusion criteria.
Anticipated start date 01/01/2007
Anticipated end date 01/01/2008
Status of trial Completed
Patient information material
Target number of participants 13
Interventions 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.
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.
Secondary outcome measure(s) No secondary outcome measures
Sources of funding Investigator initiated and funded (USA)
Trial website
Publications Results in http://www.ncbi.nlm.nih.gov/pubmed/18485819
Contact name Dr  Eugene  Lipov
  Address 2260 W. Higgins Rd.
Ste. 101
  City/town Hoffman Estates
  Zip/Postcode 60195
  Country United States of America
Sponsor Advanced Pain Centers (USA)
  Address 2260 W. Higgins Rd.
Ste 101
  City/town Hoffman Estates
  Zip/Postcode 60195
  Country United States of America
  Sponsor website: http://www.painmngt.com/
Date applied 19/04/2008
Last edited 03/06/2008
Date ISRCTN assigned 08/05/2008
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