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Stellate Ganglion Nerve Block in Treating Women With Hot Flashes

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

Status
Completed
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00879164
Enrollment
10
Registered
2009-04-09
Start date
2009-04-30
Completion date
2010-12-31
Last updated
2014-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hot Flashes

Keywords

hot flashes

Brief 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.

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.

Interventions

DRUGbupivacaine hydrochloride
OTHERquestionnaire administration

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
Mayo Clinic
Lead SponsorOTHER

Study design

Primary purpose
SUPPORTIVE_CARE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion 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

Design outcomes

Primary

MeasureTime frame
Difference in hot flash activity between baseline and week 7

Secondary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026