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OpenTrials
Completed

NCT Number: NCT00879164

Stellate Ganglion Nerve Block in Treating Women With Hot Flashes

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Early Phase 1

Primary location

Mayo Clinic

Rochester, Minnesota, 55905, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bupivacaine Hydrochloride

Drug

Questionnaire Administration

Other

Primary outcomes

  1. Difference in hot flash activity between baseline and week 7

Secondary outcomes

  1. Difference in quality of life, toxicity, and self-assessment items between baseline and week 7

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Apr 9, 2009
Registry last updated
Oct 17, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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