Stellate Ganglion Block in Men to reduce Hot Flushes

Conditions: Hot flushes due to androgen deprivation therapy
Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

Registration Number: EUCTR2013-005325-23-NL

Lead Sponsor: Rijnstate Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: Male

Target Recruitment: Not specified

Inclusion Criteria

-General criteria;
Male
Age: >18 years
Mean daily flush frequency of 10 or more, or mean hot flush score of 15 or higher
Treatment with ADT because of prostate cancer
Absence of any other cause of flushing

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 50
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

-Use of medication that affects flushing:
oestrogens, progestogens, clonidine, naloxone, paroxetine, fluoxetine, venlaflaxine, gabapentin, LHRH receptor antagonist
-Still receiving chemotherapy of radiotherapy
-Psychiatric disease
-Any unstable concurrent disease

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the short-term efficacy of stellate ganglion block on hot flush reduction versus sham procedure.;Secondary Objective: To assess the efficacy of stellate ganglion block on quality of life;Primary end point(s): Hot Flush Score;Timepoint(s) of evaluation of this end point: 4 weeks

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Quality of life, measured with 3 questionnaires:<br>a.Hot Flash-Related Daily Interference Scale (HFRDIS)<br>b.Epworth Sleepiness Scale (ESS)<br>c.PSQI (Pittsburgh Sleep Quality Index)<br>;Timepoint(s) of evaluation of this end point: 4 weeks