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Stellate Ganglion Nerve Block in Treating Women With Hot Flashes

Primary Purpose

Hot Flashes

Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
bupivacaine hydrochloride
questionnaire administration
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Hot Flashes focused on measuring hot flashes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Mayo Clinic

Outcomes

Primary Outcome Measures

Difference in hot flash activity between baseline and week 7

Secondary Outcome Measures

Difference in quality of life, toxicity, and self-assessment items between baseline and week 7

Full Information

First Posted
April 8, 2009
Last Updated
October 15, 2014
Sponsor
Mayo Clinic
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00879164
Brief Title
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

2. Study Status

Record Verification Date
October 2014
Overall Recruitment Status
Completed
Study Start Date
April 2009 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mayo Clinic
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hot Flashes
Keywords
hot flashes

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Early Phase 1
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
bupivacaine hydrochloride
Intervention Type
Other
Intervention Name(s)
questionnaire administration
Primary Outcome Measure Information:
Title
Difference in hot flash activity between baseline and week 7
Secondary Outcome Measure Information:
Title
Difference in quality of life, toxicity, and self-assessment items between baseline and week 7

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charles L. Loprinzi, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Study Chair
Facility Information:
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
20496155
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.
Results Reference
derived

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Stellate Ganglion Nerve Block in Treating Women With Hot Flashes

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