Prostate CancerNCT02295163
Stellate Ganglion Block for Hot Flushes in Men Treated With ADT
A study testing Stellate ganglion block in people with Prostate Cancer, run by Rijnstate Hospital at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Stellate ganglion block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteNetherlands
- Study dates
- Jul 2014to Jan 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Short-term Efficacy of Stellate Ganglion Block in Men to Reduce Hot Flushes Related to Androgen Deprivation Therapy
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
Read the detailed description
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
- Conditions
- Prostate Cancer
- Being tested
- Stellate ganglion block, Sham procedure
- Keywords
- Stellate ganglion block, hot flushes, androgen deprivation therapy, prostate cancer
- Medical subject headings
- Prostatic Neoplasms, Hot Flashes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stellate ganglion blockProcedure or surgery
7 ml of 0.5% bupivacaine will subsequently be injected next to the stellate ganglion to produce a sympathetic block.
Sham procedureProcedure or surgery
7 ml of 0.9 % sodium chloride will subsequently be injected next to the stellate ganglion
| Study group | Role | What they receive |
|---|---|---|
| Sham procedure | Sham comparator | injection of NACL 0,9% in the stellate ganglion Receives: Procedure: Sham procedure |
| Stellate ganglion block | Experimental | injection of Bupivacaine 0,5% in the stellate ganglion Receives: Procedure: Stellate ganglion block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hot flush score
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2014 (estimated)
- Study startJul 2014
- Primary completionJan 2021
- Study completionJan 2021
Why it stopped: no participants
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rijnstate Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jan Willem Kallewaard phd, Rijnstate Hospital
- Investigators
- jw. kallewaard, MD, Principal investigator, Rijnstate Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02295163
- Sponsor's protocol ID
- NL46979.091.13
- Status last verified
- Mar 2020
- First submitted
- 11 Nov 2014
- Last updated
- 10 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short-term Efficacy of Stellate Ganglion Block in Men to Reduce Hot Flushes Related to Androgen Deprivation Therapy
- ClinicalTrials.gov ID
- NCT02295163
- Acronym / sponsor ID
- NL46979.091.13
- Conditions
- Prostate Cancer
- Keywords
- Stellate ganglion block, hot flushes, androgen deprivation therapy, prostate cancer
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: no participants
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Rijnstate HospitalUniversity, hospital or other
- Study start
- Jul 2014 (actual)
- Primary completion
- Jan 2021 (actual)
- Study completion
- Jan 2021 (actual)
- First posted
- 20 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sham procedure | Sham comparator | Procedure: Sham procedureinjection of NACL 0,9% in the stellate ganglion |
| Stellate ganglion block | Experimental | Procedure: Stellate ganglion blockinjection of Bupivacaine 0,5% in the stellate ganglion |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stellate ganglion block7 ml of 0.5% bupivacaine will subsequently be injected next to the stellate ganglion to produce a sympathetic block. | Procedure or surgery | Stellate ganglion block |
| Sham procedure7 ml of 0.9 % sodium chloride will subsequently be injected next to the stellate ganglion | Procedure or surgery | Sham procedure |
Primary outcome
Hot flush score
Time frame: 4 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
jw. kallewaard, MD principal investigator
Rijnstate Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stellate ganglion block in people with Prostate Cancer, run by Rijnstate Hospital at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 10 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hot flush score (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2021.