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

Withdrawn

• Conditions: hot flushes; 10021112

• Registration Number: NL-OMON38339
• Lead Sponsor: Rijnstate Ziekenhuis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Withdrawn
• Sex: Not specified
• Target Recruitment: 50

Inclusion Criteria

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

Exclusion Criteria

- Use of medication that affects flushing:;o estrogens, 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
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Hot flush score: percentage reduction in hot flush score and the number of<br /><br>subjects reaching a flush score reduction >50%.<br /><br>Hot Flush score = mean daily flush frequency x flush severity<br /><br>(flush severity = mean severity score of every flush on a 1-4 scale)</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Quality of life, measured with 3 questionnaires:<br /><br>a. Hot Flash-Related Daily Interference Scale (HFRDIS)<br /><br>b. Epworth Sleepiness Scale (ESS)<br /><br>c. PSQI (Pittsburgh Sleep Quality Index)</p><br>