Stellate Ganglion Nerve Block in Treating Women With Hot Flashes

Hot Flashes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00879164
• Other study ID #: CDR0000640197
• Secondary ID: P30CA015083MC08C
• Status: Completed
• Phase: Phase 0
• First received: April 8, 2009
• Last updated: October 15, 2014
• Start date: April 2009
• Est. completion date: December 2010

Study information

• Verified date: October 2014
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Hot Flashes

Intervention

Drug:
• bupivacaine hydrochloride

Other:
• questionnaire administration

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference in hot flash activity between baseline and week 7			No
Secondary	Difference in quality of life, toxicity, and self-assessment items between baseline and week 7			Yes