Stellate Ganglion Nerve Block in Treating Women With Hot Flashes
Tracking Information | |||||
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First Received Date ICMJE | April 8, 2009 | ||||
Last Updated Date | May 9, 2011 | ||||
Start Date ICMJE | April 2009 | ||||
Primary Completion Date | December 2010 (final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Difference in hot flash activity between baseline and week 7 [ Designated as safety issue: No ] | ||||
Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | Complete list of historical versions of study NCT00879164 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE |
Difference in quality of life, toxicity, and self-assessment items between baseline and week 7 [ Designated as safety issue: Yes ] | ||||
Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Outcome Measures ICMJE | |||||
Original Other Outcome Measures ICMJE | |||||
Descriptive Information | |||||
Brief Title ICMJE | Stellate Ganglion Nerve Block in Treating Women With Hot Flashes | ||||
Official Title ICMJE | Pilot Evaluation of a Stellate Ganglion Block for the Treatment of Hot Flashes | ||||
Brief Summary | RATIONALE: A stellate ganglion nerve block may help relieve hot flashes in women. PURPOSE: This clinical trial is studying how well a stellate ganglion nerve block works in treating women with hot flashes. |
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Detailed Description | OBJECTIVES:
OUTLINE: Patients undergo fluoroscopic-guided stellate ganglion blockade using bupivacaine hydrochloride in week 1. Patients complete a hot flash diary daily and a symptom experience diary weekly in weeks 1-7 and the Profile of Mood States questionnaire in weeks 1 and 7. After completion of study treatment, patients are followed at 2 months and then monthly for 1 year. |
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Study Type ICMJE | Interventional | ||||
Study Phase | |||||
Study Design ICMJE | Primary Purpose: Supportive Care | ||||
Condition ICMJE | Hot Flashes | ||||
Intervention ICMJE |
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Study Arm (s) | |||||
Publications * | Pachman DR, Barton D, Carns PE, Novotny PJ, Wolf S, Linquist B, Kohli S, Smith DR, Loprinzi CL. Pilot evaluation of a stellate ganglion block for the treatment of hot flashes. Support Care Cancer. 2011 Jul;19(7):941-7. Epub 2010 May 23. | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Estimated Enrollment ICMJE | 10 | ||||
Completion Date | December 2010 | ||||
Primary Completion Date | December 2010 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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Gender | Female | ||||
Ages | 18 Years and older | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Location Countries ICMJE | United States | ||||
Administrative Information | |||||
NCT Number ICMJE | NCT00879164 | ||||
Other Study ID Numbers ICMJE | CDR0000640197, P30CA015083, MC08C8, 08-006796, NCI-2009-01133 | ||||
Has Data Monitoring Committee | Yes | ||||
Responsible Party | Charles L. Loprinzi, M.D., Mayo Clinic Cancer Center | ||||
Study Sponsor ICMJE | Mayo Clinic | ||||
Collaborators ICMJE | National Cancer Institute (NCI) | ||||
Investigators ICMJE |
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Information Provided By | Mayo Clinic | ||||
Verification Date | May 2011 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |