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ISRCTN
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ISRCTN14318565
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ClinicalTrials.gov identifier
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Public title
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Stellate ganglion block reduces hot flushes and night awakenings in breast cancer survivors: a pilot study
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Scientific title
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Acronym
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N/A
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Serial number at source
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N/A
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Study hypothesis
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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.
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Ethics approval
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Ethics approval received from the Alexian Brothers Hospital Network Institutional Review Board on the 5th October 2006.
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Study design
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Interventional, single-centre, single arm, non-placebo controlled trial
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Countries of recruitment
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United States of America
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Disease/condition/study domain
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Hot flushes, night awakenings
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Participants - inclusion criteria
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1. 30 - 70 year old female breast cancer survivors
2. American Society of Anaesthesiologists (ASA) scores 3 or below
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Participants - exclusion criteria
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Does not comply with the above inclusion criteria.
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Anticipated start date
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01/01/2007
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Anticipated end date
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01/01/2008
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Status of trial
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Completed
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Patient information material
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Target number of participants
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13
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Interventions
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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.
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Primary outcome measure(s)
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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.
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Secondary outcome measure(s)
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No secondary outcome measures.
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Sources of funding
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Investigator initiated and funded (USA)
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Trial website
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Publications
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Contact name
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Dr
Eugene
Lipov
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Address
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2260 W. Higgins Rd.
Ste. 101
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City/town
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Hoffman Estates
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Zip/Postcode
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60195
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Country
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United States of America
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Sponsor
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Advanced Pain Centers (USA)
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Address
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2260 W. Higgins Rd.
Ste 101
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City/town
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Hoffman Estates
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Zip/Postcode
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60195
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Country
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United States of America
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Sponsor website:
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http://www.painmngt.com/
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Date applied
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19/04/2008
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Last edited
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08/05/2008
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Date ISRCTN assigned
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08/05/2008
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