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NCT02295163 Clinical Trial

Stellate Ganglion Block for Hot Flushes in Men Treated With ADT

Prostate Cancer Clinical Trial

Official title:
Short-term Efficacy of Stellate Ganglion Block in Men to Reduce Hot Flushes Related to Androgen Deprivation Therapy

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT02295163
Other study ID # NL46979.091.13
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
Start date July 2014
Est. completion date January 2021

Study information
Verified date March 2020
Source Rijnstate Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

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

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date January 2021
Est. primary completion date January 2021
Accepts healthy volunteers No
Gender Male
Age group 18 Years and older
Eligibility Inclusion Criteria: - Male - Age: >18 years - Mean daily flush frequency of 10 or more and a hot flush score of 15 or more - Treatment with ADT because of prostate cancer - Absence of any other cause of flushing Exclusion Criteria: - Use of medication that affects flushing: oestrogens, progestogens, clonidine, naloxone, paroxetine, fluoxetine, venlafaxine, gabapentin, luteinizing hormone-releasing hormone receptor antagonist - Still receiving chemotherapy of radiotherapy - Psychiatric disease - Any unstable concurrent disease - Allergic reactions against bupivacaine or contrast media.

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Stellate ganglion block
7 ml of 0.5% bupivacaine will subsequently be injected next to the stellate ganglion to produce a sympathetic block.
• Sham procedure
7 ml of 0.9 % sodium chloride will subsequently be injected next to the stellate ganglion

Locations
Country Name City State
Netherlands Rijnstate Hospital Arnhem Gelderland

Sponsors (1)
Lead Sponsor Collaborator
Rijnstate Hospital

Country where clinical trial is conducted

Netherlands, 

Outcome
Type Measure Description Time frame Safety issue
Primary Hot flush score 4 weeks
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