Stellate Ganglion Nerve Block in Treating Women With Hot Flashes

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00879164
First received: April 8, 2009
Last updated: May 9, 2011
Last verified: May 2011

April 8, 2009
May 9, 2011
April 2009
December 2010   (final data collection date for primary outcome measure)
Difference in hot flash activity between baseline and week 7 [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00879164 on ClinicalTrials.gov Archive Site
Difference in quality of life, toxicity, and self-assessment items between baseline and week 7 [ Designated as safety issue: Yes ]
Same as current
 
 
 
Stellate Ganglion Nerve Block in Treating Women With Hot Flashes
Pilot Evaluation of a Stellate Ganglion Block for the Treatment of 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.

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.

Interventional
 
Primary Purpose: Supportive Care
Hot Flashes
  • Drug: bupivacaine hydrochloride
  • Other: questionnaire administration
 
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. Epub 2010 May 23.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
10
December 2010
December 2010   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00879164
CDR0000640197, P30CA015083, MC08C8, 08-006796, NCI-2009-01133
Yes
Charles L. Loprinzi, M.D., Mayo Clinic Cancer Center
Mayo Clinic
National Cancer Institute (NCI)
Study Chair: Charles L. Loprinzi, MD Mayo Clinic
Mayo Clinic
May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP