Stellate Ganglion Block for Hot Flushes in Men Treated With ADT

Not Applicable

Withdrawn

• Conditions: Prostate Cancer
• Interventions: Procedure: Sham procedure; Procedure: Stellate ganglion block

• Registration Number: NCT02295163
• Lead Sponsor: Rijnstate Hospital

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

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 Timeline

• Study Start: 2014-07
• Study First Submitted: 2014-11-11
• Study First Submitted QC: 2014-11-17
• Study First Posted: 2014-11-20
• Status Verified: 2020-03
• Primary Completion: 2021-01
• Study Completion: 2021-01
• Last Update Submitted: 2021-03-09
• Last Update Posted: 2021-03-10

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Male
• Target Recruitment: Not specified

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham procedure	Sham procedure	injection of NACL 0,9% in the stellate ganglion
Stellate ganglion block	Stellate ganglion block	injection of Bupivacaine 0,5% in the stellate ganglion

Primary Outcome Measures

Name	Time	Method
Hot flush score	4 weeks

Trial Locations

Locations (1)

Rijnstate Hospital; 🇳🇱 Arnhem, Gelderland, Netherlands