Stellate Ganglion Block for Hot Flushes in Men Treated With ADT

Study Overview
=================
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

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

Conditions
-----------------
Prostate Cancer

Intervention / Treatment
-----------------
* Procedure: Stellate ganglion block
* Procedure: Sham procedure


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Sham procedure<br>injection of NACL 0,9% in the stellate ganglion | Procedure: Sham procedure<br>* 7 ml of 0.9 % sodium chloride will subsequently be injected next to the stellate ganglion<br>|
| Experimental: Stellate ganglion block<br>injection of Bupivacaine 0,5% in the stellate ganglion | Procedure: Stellate ganglion block<br>* 7 ml of 0.5% bupivacaine will subsequently be injected next to the stellate ganglion to produce a sympathetic block.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hot flush score |  | 4 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Stellate ganglion block, hot flushes, androgen deprivation therapy, prostate cancer