To assess the short-term efficacy of stellate ganglion block on hot flush reduction versus sham procedure
ID
Source
Brief title
Condition
- Hypothalamus and pituitary gland disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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)
Background 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 succesfull
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.
Stellate-ganglion blocks have been done safely for more than 60 years in
patients for various pain conditions. Several studies have demonstated
promising results in women with severe flushes. It has not been studied in men,
but in theory it should be just as effective.
Study objective
To assess the short-term efficacy of stellate ganglion block on hot flush
reduction versus sham procedure
Study design
-Single center: Rijnstate Hospital, Arnhem, The Netherlands
-Setting: outpatient setting
-Study period: 1-1-2014 to 1-11-2014
-Screening: Recording of flushes by diary for a period of 7 days. Minimum of
10 flushes per day or a hot flush score of 15 or more is required
-After inclusion:
-Week 0:
Start recording of flushes by diary 24 hrs/day
Questionnaires: HFRDIS, PSQI, ESS
Venous blood samples of LH, FSH, estradiol, SHBG, albumin and testosterone
-Week 1:
Day 1: Randomization and SGB/sham procedure will be performed by Dr Kallewaard,
anesthesiologist
-Week 1-4:
Continue recording of flushes by diary
-Week 4;
Questionnaires: HFRDIS, PSQI, ESS
Venous blood samples of LH, FSH, estradiol, SHBG, albumin and testosterone
Intervention
stellate ganglion block versus sham-procedure
Study burden and risks
Burden mainly consists of reporting in the diary. The risks are very small and
the procedure minimally invasive.
Wagnerlaan 55
Arnhem 6800 TA
NL
Wagnerlaan 55
Arnhem 6800 TA
NL
Listed location countries
Age
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
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2013-005325-23-NL |
| CCMO | NL46979.091.13 |