Status:
COMPLETED
Stellate Ganglion Nerve Block in Treating Women With Hot Flashes
Lead Sponsor:
Mayo Clinic
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Hot Flashes
Eligibility:
FEMALE
18+ years
Phase:
EARLY_PHASE1
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 fl...
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 stella...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2010
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00879164
Start Date
April 1 2009
End Date
December 1 2010
Last Update
October 17 2014
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Mayo Clinic
Rochester, Minnesota, United States, 55905