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
About this trial
This is an interventional supportive care trial for Hot Flashes focused on measuring hot flashes
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
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
NCT ID
NCT00879164
First Posted
April 8, 2009
Last Updated
October 15, 2014
Sponsor
Mayo Clinic
Collaborators
National Cancer Institute (NCI)
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
Learn more about this trial
Stellate Ganglion Nerve Block in Treating Women With Hot Flashes
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