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


N/A
18 Years
N/A
Not Enrolling
Female
Hot Flashes

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Trial Information

Pilot Evaluation of a Stellate Ganglion Block for the Treatment of 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.

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

Type of Study:

Interventional

Study Design:

Primary Purpose: Supportive Care

Outcome Measure:

Difference in hot flash activity between baseline and week 7

Safety Issue:

No

Principal Investigator

Charles L. Loprinzi, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Mayo Clinic

Authority:

United States: Federal Government

Study ID:

CDR0000640197

NCT ID:

NCT00879164

Start Date:

April 2009

Completion Date:

December 2010

Related Keywords:

  • Hot Flashes
  • hot flashes
  • Ganglion Cysts
  • Hot Flashes

Name

Location

Mayo ClinicRochester, Minnesota  55905