- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00879164
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Early Phase 1
Contacts and Locations
Study Locations
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Minnesota
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Rochester, Minnesota, United States, 55905
- Mayo Clinic
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: SUPPORTIVE_CARE
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Difference in hot flash activity between baseline and week 7
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Secondary Outcome Measures
Outcome Measure |
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Difference in quality of life, toxicity, and self-assessment items between baseline and week 7
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Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CDR0000640197
- P30CA015083 (U.S. NIH Grant/Contract)
- MC08C8 (OTHER: Mayo Clinic Cancer Center)
- 08-006796 (OTHER: Mayo Clinic IRB)
- NCI-2009-01133 (OTHER: NCI-CTRP)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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