Hot FlashesEarly Phase 1NCT00879164
Stellate Ganglion Nerve Block in Treating Women With Hot Flashes
A Early Phase 1 study testing bupivacaine hydrochloride and questionnaire administration in people with Hot Flashes, run by Mayo Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Hot Flashes
- What is being tested?
- bupivacaine hydrochloride and questionnaire administration
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2009to Dec 2010
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Hot Flashes
- Being tested
- bupivacaine hydrochloride, questionnaire administration
- Keywords
- hot flashes
- Medical subject headings
- Hot Flashes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bupivacaine hydrochlorideDrug
questionnaire administrationOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in hot flash activity between baseline and week 7
Secondary outcomes (1)
Difference in quality of life, toxicity, and self-assessment items between baseline and week 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2009 (estimated)
- Study startApr 2009
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hot FlashesStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Supportive care
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Charles L. Loprinzi, MD, Study chair, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00879164
- Sponsor's protocol ID
- CDR0000640197
- Other IDs
- P30CA015083, MC08C8, 08-006796, NCI-2009-01133
- Status last verified
- Oct 2014
- First submitted
- 8 Apr 2009
- Last updated
- 17 Oct 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 20496155
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Evaluation of a Stellate Ganglion Block for the Treatment of Hot Flashes
- ClinicalTrials.gov ID
- NCT00879164
- Acronym / sponsor ID
- CDR0000640197
- Conditions
- Hot Flashes
- Keywords
- hot flashes
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Apr 2009
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 9 Apr 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bupivacaine hydrochloride | Drug | – |
| questionnaire administration | Other | – |
Primary outcome
Difference in hot flash activity between baseline and week 7
1 secondary outcome
Difference in quality of life, toxicity, and self-assessment items between baseline and week 7
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2014.
- Derived from this study: PubMed 20496155Pachman 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charles L. Loprinzi, MD study chair
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing bupivacaine hydrochloride and questionnaire administration in people with Hot Flashes, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in hot flash activity between baseline and week 7. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00879164, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2014.