Stellate Ganglion Nerve Block in Treating Women With Hot Flashes

Mayo Clinic

Status and phase: Completed; Early Phase 1

Conditions: Hot Flashes

Treatments: Other: questionnaire administration; Drug: bupivacaine hydrochloride

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00879164

P30CA015083 (U.S. NIH Grant/Contract)

NCI-2009-01133 (Other Identifier)

08-006796 (Other Identifier)

CDR0000640197

MC08C8 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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