Stellate Ganglion Nerve Block in Treating Women With Hot Flashes

Study Overview
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Brief Summary
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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.

Detailed Description
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OBJECTIVES: 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.

Official Title
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Pilot Evaluation of a Stellate Ganglion Block for the Treatment of Hot Flashes

Conditions
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Hot Flashes

Intervention / Treatment
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* Drug: bupivacaine hydrochloride
* Other: questionnaire administration


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: bupivacaine hydrochloride|nan|
|Other: questionnaire administration|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in hot flash activity between baseline and week 7 |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in quality of life, toxicity, and self-assessment items between baseline and week 7 |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hot flashes