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Stellate Ganglion Nerve Block in Treating Women With Hot Flashes - NCT00879164-55905(Clinical Trial 283409)



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City:  Rochester
State:  
MN
Zip Code: 55905
Conditions: Hot Flashes
Purpose: 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.
Study summary: 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.
Criteria: 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
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Data Source: ClinicalTrials.gov
Date Processed: November 11, 2010
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