Stellate Ganglion Block for Hot Flushes in Men Treated With ADT

NCT02295163 | Withdrawn

• 1 other identifier: NL46979.091.13
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Conditions

Prostate Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Hot flush score

  4 weeks

Study Arms (2)

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

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

Sham procedure PROCEDURE

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

Sham procedure

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rijnstate Hospital: lead

Study Sites (1)

Rijnstate Hospital

Arnhem, Gelderland, 6815 AD, Netherlands

Location

MeSH Terms

Conditions

Prostatic Neoplasms; Hot Flashes

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• jw. kallewaard, MD

  Rijnstate Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 11, 2014
• First Posted: November 20, 2014
• Study Start: July 1, 2014
• Primary Completion: January 1, 2021
• Study Completion: January 1, 2021
• Last Updated: March 10, 2021

Record last verified: 2020-03

Locations

NL (1)