Stellate Ganglion Nerve Block in Treating Women With Hot Flashes

This study has been completed.
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Mayo Clinic Identifier:
First received: April 8, 2009
Last updated: October 15, 2014
Last verified: October 2014

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.

Condition Intervention Phase
Hot Flashes
Drug: bupivacaine hydrochloride
Other: questionnaire administration
Phase 0

Study Type: Interventional
Study Design: Primary Purpose: Supportive Care
Official Title: Pilot Evaluation of a Stellate Ganglion Block for the Treatment of Hot Flashes

Resource links provided by NLM:

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Difference in hot flash activity between baseline and week 7 [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Difference in quality of life, toxicity, and self-assessment items between baseline and week 7 [ Designated as safety issue: Yes ]

Estimated Enrollment: 10
Study Start Date: April 2009
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Detailed Description:


  • 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.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No


  • 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)


  • 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


  • 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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Please refer to this study by its identifier: NCT00879164

United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
National Cancer Institute (NCI)
Study Chair: Charles L. Loprinzi, MD Mayo Clinic
  More Information

Additional Information:
No publications provided by Mayo Clinic

Additional publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Mayo Clinic Identifier: NCT00879164     History of Changes
Other Study ID Numbers: CDR0000640197, P30CA015083, MC08C8, 08-006796, NCI-2009-01133
Study First Received: April 8, 2009
Last Updated: October 15, 2014
Health Authority: United States: Federal Government

Keywords provided by Mayo Clinic:
hot flashes

Additional relevant MeSH terms:
Hot Flashes
Signs and Symptoms
Anesthetics, Local
Central Nervous System Agents
Central Nervous System Depressants
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses processed this record on December 01, 2015