Stellate Ganglion Block for Hot Flushes in Men Treated With ADT

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

Status

Withdrawn

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02295163

Enrollment

Registered

2014-11-20

Start date

2014-07-31

Completion date

2021-01-31

Last updated

2021-03-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

Keywords

Stellate ganglion block, hot flushes, androgen deprivation therapy, prostate cancer

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

Interventions

PROCEDUREStellate ganglion block

7 ml of 0.5% bupivacaine will subsequently be injected next to the stellate ganglion to produce a sympathetic block.

PROCEDURESham procedure

7 ml of 0.9 % sodium chloride will subsequently be injected next to the stellate ganglion

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

MALE

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame
Hot flush score	4 weeks

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026