Stellate Ganglion Nerve Block in Treating Women With Hot Flashes
NCT ID: NCT00879164
Last Updated: 2014-10-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
EARLY_PHASE1
10 participants
INTERVENTIONAL
2009-04-30
2010-12-31
Brief Summary
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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
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* To evaluate the impact of stellate ganglion blockade on hot flash scores.
* To evaluate the toxicity of stellate ganglion blockade.
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.
Conditions
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Study Design
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SUPPORTIVE_CARE
Interventions
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bupivacaine hydrochloride
questionnaire administration
Eligibility Criteria
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Inclusion Criteria
* Presence of hot flashes for ≥ 1 month prior to study registration
* Hot flashes considered bothersome (defined by their occurrence of ≥ 28 times per week and of sufficient severity to make the patient desire therapeutic intervention)
* Use of more conventional hot flash treatments (including newer antidepressants and gabapentin) have failed to control hot flashes (as defined by the patient)
PATIENT CHARACTERISTICS:
* ECOG performance status 0-1
* Life expectancy ≥ 6 months
* Not of childbearing potential, as judged by the attending clinician
* Able to complete questionnaires alone or with assistance
* No evidence of an active malignancy
* No von Willebrand's disease or other bleeding disorders
* No allergy to chlorhexidine or bupivacaine
PRIOR CONCURRENT THERAPY:
* More than 4 weeks since prior and no concurrent antineoplastic chemotherapy, androgens, estrogens, or progestational agents
* Tamoxifen, raloxifene, or aromatase inhibitors allowed provided the patient has been on a constant dose for ≥ 4 weeks and continues to receive medication during study treatment
* More than 10 days since prior and no concurrent anticoagulants (e.g., aspirin, clopidogrel, ticlopidine, or warfarin)
* Concurrent heparin flushes for venous catheter allowed
* No concurrent use of other agents (e.g., megestrol acetate, soy, clonidine, or Bellergal) for treating hot flashes
* Vitamin E, gabapentin, or antidepressants allowed provided the patient has been on a stable dose for \> 30 days and continues to receive medication during study treatment
18 Years
FEMALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
Mayo Clinic
OTHER
Responsible Party
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Principal Investigators
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Charles L. Loprinzi, MD
Role: STUDY_CHAIR
Mayo Clinic
Locations
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Mayo Clinic
Rochester, Minnesota, United States
Countries
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References
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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. doi: 10.1007/s00520-010-0907-9. Epub 2010 May 23.
Other Identifiers
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MC08C8
Identifier Type: OTHER
Identifier Source: secondary_id
08-006796
Identifier Type: OTHER
Identifier Source: secondary_id
NCI-2009-01133
Identifier Type: OTHER
Identifier Source: secondary_id
CDR0000640197
Identifier Type: -
Identifier Source: org_study_id
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