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Stellate Ganglion Nerve Block in Treating Women With Hot Flashes

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00879164
First received: April 8, 2009
Last updated: October 15, 2014
Last verified: October 2014
  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.


Condition Intervention Phase
Hot Flashes
Drug: bupivacaine hydrochloride
Other: questionnaire administration
Early Phase 1

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

Secondary Outcome Measures:
  • Difference in quality of life, toxicity, and self-assessment items between baseline and week 7

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:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00879164

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Mayo Clinic
ClinicalTrials.gov Identifier: NCT00879164     History of Changes
Other Study ID Numbers: CDR0000640197
P30CA015083 ( US NIH Grant/Contract Award Number )
MC08C8 ( Other Identifier: Mayo Clinic Cancer Center )
08-006796 ( Other Identifier: Mayo Clinic IRB )
NCI-2009-01133 ( Other Identifier: NCI-CTRP )
Study First Received: April 8, 2009
Last Updated: October 15, 2014

Keywords provided by Mayo Clinic:
hot flashes

Additional relevant MeSH terms:
Hot Flashes
Signs and Symptoms
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on May 25, 2017