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| ID | Type | Description | Link |
|---|---|---|---|
| P30CA015083 | U.S. NIH Grant/Contract | View source | |
| MC08C8 | Other Identifier | Mayo Clinic Cancer Center | |
| 08-006796 | Other Identifier | Mayo Clinic IRB | |
| NCI-2009-01133 | Other Identifier | NCI-CTRP |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
OBJECTIVES:
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| bupivacaine hydrochloride | Drug | |||
| questionnaire administration | Other |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in hot flash activity between baseline and week 7 |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in quality of life, toxicity, and self-assessment items between baseline and week 7 |
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DISEASE CHARACTERISTICS:
Presence of hot flashes for ≥ 1 month prior to study registration
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:
PRIOR CONCURRENT THERAPY:
More than 4 weeks since prior and no concurrent antineoplastic chemotherapy, androgens, estrogens, or progestational agents
More than 10 days since prior and no concurrent anticoagulants (e.g., aspirin, clopidogrel, ticlopidine, or warfarin)
No concurrent use of other agents (e.g., megestrol acetate, soy, clonidine, or Bellergal) for treating hot flashes
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| Name | Affiliation | Role |
|---|---|---|
| Charles L. Loprinzi, MD | Mayo Clinic | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20496155 | Derived | 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. |
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| ID | Term |
|---|---|
| D019584 | Hot Flashes |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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| D000588 |
| Amines |