Stellate Ganglion Block for Hot Flushes in Men Treated With ADT
Study Details
Study Description
Brief Summary
Androgen deprivation therapy (ADT) is widely used as standard therapy in the treatment of locally advanced and metastatic prostate cancer. Hot flushes and night sweats are one of the main side-effects of ADT. There are no successful and well-tolerable treatment options available. A possible treatment for hot flushes is stellate-ganglion block (SGB), used as a means of interrupting parts of the sympathetic nervous system involved in temperature regulation.
Objective of this study:
To assess the short-term efficacy of stellate ganglion block on hot flush reduction versus sham procedure
Condition or Disease | Intervention/Treatment | Phase |
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N/A |
Detailed Description
Androgen deprivation therapy (ADT) is widely used as standard therapy in the treatment of locally advanced and metastatic prostate cancer. Hot flushes and night sweats are one of the main side-effects of ADT. There are no successful and well-tolerable treatment options available. A possible treatment for hot flushes is stellate-ganglion block (SGB), used as a means of interrupting parts of the sympathetic nervous system involved in temperature regulation.
Objective of this study
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Sham Comparator: Sham procedure injection of NACL 0,9% in the stellate ganglion |
Procedure: Sham procedure
7 ml of 0.9 % sodium chloride will subsequently be injected next to the stellate ganglion
|
Experimental: Stellate ganglion block injection of Bupivacaine 0,5% in the stellate ganglion |
Procedure: Stellate ganglion block
7 ml of 0.5% bupivacaine will subsequently be injected next to the stellate ganglion to produce a sympathetic block.
|
Outcome Measures
Primary Outcome Measures
- Hot flush score [4 weeks]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Male
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Age: >18 years
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Mean daily flush frequency of 10 or more and a hot flush score of 15 or more
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Treatment with ADT because of prostate cancer
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Absence of any other cause of flushing
Exclusion Criteria:
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Use of medication that affects flushing: oestrogens, progestogens, clonidine, naloxone, paroxetine, fluoxetine, venlafaxine, gabapentin, luteinizing hormone-releasing hormone receptor antagonist
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Still receiving chemotherapy of radiotherapy
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Psychiatric disease
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Any unstable concurrent disease
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Allergic reactions against bupivacaine or contrast media.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Rijnstate Hospital | Arnhem | Gelderland | Netherlands | 6815 AD |
Sponsors and Collaborators
- Rijnstate Hospital
Investigators
- Principal Investigator: jw. kallewaard, MD, Rijnstate Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- NL46979.091.13