Stellate Ganglion Block for Hot Flushes in Men Treated Wi... | NCT02295163

Studies
Stellate Ganglion Block for Hot Flushes in Men Treated With ADT

NCT02295163

Sponsor

Rijnstate Hospital

Status

Withdrawn

Last Update Posted

Mar 10, 2021Actual

Enrollment

0Actual

Phase

Not Applicable

Conditions

Prostate Cancer

Interventions

Stellate ganglion block
Sham procedure

Countries

Netherlands

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2020

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

no participants

Expanded Access Info

Start Date

Jul 2014Actual

Primary Completion Date

Jan 2021Actual

Completion Date

Jan 2021Actual

First Submitted Date

Nov 11, 2014

First Submission Date that Met QC Criteria

Nov 17, 2014

First Posted Date

Nov 20, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 9, 2021

Last Update Posted Date

Mar 10, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Objective of this study

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Sham procedure	Sham Comparator	injection of NACL 0,9% in the stellate ganglion	Procedure: Sham procedure
Stellate ganglion block	Experimental	injection of Bupivacaine 0,5% in the stellate ganglion	Procedure: Stellate ganglion block

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Stellate ganglion block	Procedure	7 ml of 0.5% bupivacaine will subsequently be injected next to the stellate ganglion to produce a sympathetic block.	Stellate ganglion block

Measure	Description	Time Frame
Hot flush score		4 weeks

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
jw. kallewaard, MD	Rijnstate Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Rijnstate Hospital		Arnhem	Gelderland	6815 AD	Netherlands

Condition Browse Module

MeSH Terms

ID	Term
D011471	Prostatic Neoplasms
D019584	Hot Flashes

Ancestor Terms

ID	Term
D005834	Genital Neoplasms, Male
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided