Clinical trial NCT00879164: Stellate Ganglion Nerve Block in Treating Women With Hot Flashes
Official title: Pilot Evaluation of a Stellate Ganglion Block for the Treatment of Hot Flashes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Hot Flashes
Keywords: hot flashes
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2009-04-09
Enrollment: 10
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility 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

Primary outcomes:
measure: Difference in hot flash activity between baseline and week 7
Secondary outcomes:
measure: Difference in quality of life, toxicity, and self-assessment items between baseline and week 7
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Charles L. Loprinzi, MD
role: STUDY_CHAIR
References:
citation: Pachman DR, Barton D, Carns PE, Novotny PJ, Wolf S, Linquist B, Kohli S, Smith DR, Loprinzi CL. Pilot evaluation of a stellate ganglion block for the treatment of hot flashes. Support Care Cancer. 2011 Jul;19(7):941-7. doi: 10.1007/s00520-010-0907-9. Epub 2010 May 23.