Stellate Ganglion Block for Hot Flushes in Men Treated With ADT

Sponsor
Rijnstate Hospital (Other)
Overall Status
Withdrawn
CT.gov ID
NCT02295163
Collaborator
(none)
0
1
2
78.1
0

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Procedure: Stellate ganglion block
  • Procedure: Sham procedure
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
Short-term Efficacy of Stellate Ganglion Block in Men to Reduce Hot Flushes Related to Androgen Deprivation Therapy
Actual Study Start Date :
Jul 1, 2014
Actual Primary Completion Date :
Jan 1, 2021
Actual Study Completion Date :
Jan 1, 2021

Arms and Interventions

Arm Intervention/Treatment
Sham Comparator: Sham procedure

injection of NACL 0,9% in the stellate ganglion

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

Experimental: Stellate ganglion block

injection of Bupivacaine 0,5% in the stellate ganglion

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

Outcome Measures

Primary Outcome Measures

  1. Hot flush score [4 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Rijnstate Hospital Arnhem Gelderland Netherlands 6815 AD

Sponsors and Collaborators

  • Rijnstate Hospital

Investigators

  • Principal Investigator: jw. kallewaard, MD, Rijnstate Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Jan Willem Kallewaard phd, Principal Investigator, Rijnstate Hospital
ClinicalTrials.gov Identifier:
NCT02295163
Other Study ID Numbers:
  • NL46979.091.13
First Posted:
Nov 20, 2014
Last Update Posted:
Mar 10, 2021
Last Verified:
Mar 1, 2020
Keywords provided by Jan Willem Kallewaard phd, Principal Investigator, Rijnstate Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 10, 2021