Stellate Ganglion Nerve Block in Treating Women With Hot Flashes

• Status: Completed
• Trial end date: 2010-12-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mayo Clinic
• Collaborator: National Cancer Institute (NCI)
• Treatments: Bupivacaine

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