Stellate Ganglion Block for Hot Flushes in Men Treated With ADT

Rijnstate Hospital

Status: Withdrawn

Conditions: Prostate Cancer

Treatments: Procedure: Sham procedure; Procedure: Stellate ganglion block

Study type: Interventional

Funder types: Other

Identifiers

NCT02295163

NL46979.091.13

Details and patient eligibility

About

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

Full 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

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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0 participants in 2 patient groups

Sham procedure

Sham Comparator group

Description:

injection of NACL 0,9% in the stellate ganglion

Treatment:

Procedure: Sham procedure

Stellate ganglion block

Experimental group

Description:

injection of Bupivacaine 0,5% in the stellate ganglion

Treatment:

Procedure: Stellate ganglion block