FindTrial
Sign In

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

Short-term Efficacy of Stellate Ganglion Block in Men to reduce Hot Flushes related to Androgen Deprivation Therapy - SBG for hot flushes in men treated with ADT

Status
Unknown
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON38339
Enrollment
50
Registered
2014-02-21
Start date
Unknown
Completion date
Unknown
Last updated
2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

hot flushes

Interventions

stellate ganglion block versus sham-procedure

Sponsors

Rijnstate Ziekenhuis
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
Hot flush score: percentage reduction in hot flush score and the number of subjects reaching a flush score reduction >50%. Hot Flush score = mean daily flush frequency x flush severity (flush severity = mean severity score of every flush on a 1-4 scale)—

Secondary

MeasureTime frame
Quality of life, measured with 3 questionnaires: a. Hot Flash-Related Daily Interference Scale (HFRDIS) b. Epworth Sleepiness Scale (ESS) c. PSQI (Pittsburgh Sleep Quality Index)—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)