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Clinical Trial Details — Status: Withdrawn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
• Status: Withdrawn
• Phase: N/A
• 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
• 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• Status: Withdrawn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.

Related Conditions & MeSH terms

• Ganglion Cysts
• Hot Flashes
• Prostate Cancer
• Prostatic Neoplasms

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