Prostate CancerPhase 4NCT03796195
(SGB) in Men Treated for Prostate Cancer Improve Hot Flashes
A Phase 4 study testing .5% Bupivacaine in people with Prostate Cancer and Hot Flashes, run by Northwestern University at 1 site in United States.
Trial summary
Androgen Deprivation Therapy (ADT) is a critical component of advanced prostate cancer treatment but causes numerous adverse effects including decreased bone mass, decreased muscle mass, gynecomastia, erectile dysfunction, loss of sexual desire, depression, disordered sleep, urinary symptoms, and hot flashes (HF). Read more about this study
- Who is it for?
- Ages 18 to 65 years, men only
- Conditions the study is for
- Prostate Cancer, Hot Flashes
- What is being tested?
- .5% Bupivacaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Nov 2019to 16 Jul 2021
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 65 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men with prostate cancer (with or without metastatic disease) on ADT for at least 2 months
- Age less than 65 years
- Body Mass Index (BMI) less than 32
- Willingness to undergo image guided intervention
- Greater than 28 hot flashes per week.
Who cannot join
- Conditions that preclude SGB or sham intervention (e.g., anatomic abnormalities of the anterior neck or cervical spine; metastatic disease in or near the cervical spine; goiter;cardiac/pulmonary compromise; sleep apnea; acute illness/infection; coagulopathy or bleeding disorder; allergic reactions/contraindications to a local anesthetic or contrast dye)
- Current treatment of prostate cancer with radium or chemotherapy
- Use of treatments in the past two months that can affect HF (e.g., testosterone or androgen supplementation) Note: SSRIs, serotonin norepinephrine uptake inhibitors, and membrane stabilizers will be allowed but must be on stable unchanged dose for at least 8 weeks)
- Inability to write, speak, or read in English
Trial locations and contacts
1 site in 1 country.
United States1 site
Northwestern Memorial Hospital
Chicago, Illinois, 60611
About this study
Official title: Does Stellate Ganglion Blockade (SGB) in Men Treated for Prostate Cancer Improve Hot Flashes? A Pilot Prospective Cohort Study
Androgen Deprivation Therapy (ADT) is a critical component of advanced prostate cancer treatment but causes numerous adverse effects including decreased bone mass, decreased muscle mass, gynecomastia, erectile dysfunction, loss of sexual desire, depression, disordered sleep, urinary symptoms, and hot flashes (HF). HF are unpleasant paroxysmal episodes of flushing, sweating with vasodilation of the face, neck, and chest. These episodes can last for seconds to minutes and are often associated with night sweats, anxiety, and insomnia and have negative effects on quality of life.
Stellate ganglion blockade (SGB) with local anesthetic may be an effective treatment of HF in men on ADT, but has not been studied in any published clinical trials.
Read more
The stellate ganglion is a neural structure in the anterior cervical spine region and is part of the sympathetic nervous system. It has been injected safely in the practice of pain management for more than 50 years in cases of post herpetic neuralgia (shingles), complex regional pain syndrome (CRPS) and other painful neuropathies as well as some types of cardiac dysrhythmias.
Given the frequency and severity and interference of HF in men on ADT for prostate cancer, in addition to the negative effects HF impose on this patient population and a paucity of effective treatments, finding alternative treatments for HF in this population is needed.
- Conditions
- Prostate Cancer, Hot Flashes
- Being tested
- .5% Bupivacaine
- Keywords
- Stelate Ganglion Block
- 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.
.5% BupivacaineDrug
Also called Right sided stelate ganglion block (SGB)
Ultrasound guided right sided stelate ganglion block using .5% bupivacaine (5mLs)
| Study group | Role | What they receive |
|---|---|---|
| .5% Bupivacaine | Experimental | Guided right sided stelate ganglion block using .5% bupivacaine (5mLs) Receives: Drug: .5% Bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hot Flash Frequency Change Baseline to 3 Months After Treatment.
Change in mean daily hot flashes using a self-report hot flash diary from baseline to 3 months after stellate ganglion block.
Measured: 3 months after SGB procedure
Secondary outcomes (3)
Change in Hot Flash Severity Baseline to 3 Months After Stellate Ganglion Block
The change in hot flash severity (hot flash frequency x hot flash intensity) between baseline and 3 months after SGB. Hot flash severity is determined using the mean frequency= ((Fmo+Fse))7 where FMi, Fmo and Fse are the weekly total number of mild, moderate or severe HF events. The mean severity= (Fmi+2x Fmo + 3 x Fse)/7 where FMI, Fmo and Fse are the weekly total number of mild, moderate or severe/very severe hot flash events in the case of mean severity, frequency of mild vasomotor symptoms is not counted at baseline.
Measured: 3 months after stellate ganglion block
PROMIS SF4a Score 4 Weeks After Stellate Ganglion Block.
PROMIS SF4a (sleep) Patient Reportee Outcomes Measurement Information System. The PROMIS SF4a is a 4 item questionnaire that queries sleep duration, quality and interruption. This instrument accesses self reported perceptions of sleep quality, sleep depth and restoratoin associated with sleep. This includes perceived difficulties and concerns with getting to sleep or staying asleep, as well as perceptions of the adequacy and satisfaction with sleep. The 4 items are scored 1-5 where 1 is good quality and 5 is poor quality for a total score range of 4 (good quality) to 20 (poor quality).
Measured: 4 weeks after stellate ganglion block
Patient Global Impression of Change Score (PGIC)
The PGIC assesses the participants improvement in hot flashes from the time of the stellate ganglion block to 4 weeks after the procedure. The PGIC queries how much the hot flashes have improved on a scale of 1 (very much improved) to 7 (very much worse).
Measured: 4 weeks after stellate ganglion block
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2019
- Study start13 Nov 2019
- Primary completion16 Jul 2021
- Study completion16 Jul 2021
Why it stopped: Enrollment issues
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Walega, Northwestern University
- Investigators
- David Walega, MD, MS, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03796195
- Sponsor's protocol ID
- STU00208657
- Status last verified
- Jan 2023
- First submitted
- 3 Jan 2019
- Last updated
- 25 Jan 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gonzalez BD, Small BJ, Cases MG, Williams NL, Fishman MN, Jacobsen PB, Jim HSL. Sleep disturbance in men receiving androgen deprivation therapy for prostate cancer: The role of hot flashes and nocturia. Cancer. 2018 Feb 1;124(3):499-506. doi: 10.1002/cncr.31024. Epub 2017 Oct 26.
PubMed 29072790Dosani M, Morris WJ, Tyldesley S, Pickles T. The Relationship between Hot Flashes and Testosterone Recovery after 12 Months of Androgen Suppression for Men with Localised Prostate Cancer in the ASCENDE-RT Trial. Clin Oncol (R Coll Radiol). 2017 Oct;29(10):696-701. doi: 10.1016/j.clon.2017.06.009. Epub 2017 Jul 13.
PubMed 28712786Grunfeld EA, Hunter MS, Yousaf O. Men's experience of a guided self-help intervention for hot flushes associated with prostate cancer treatment. Psychol Health Med. 2017 Apr;22(4):425-433. doi: 10.1080/13548506.2016.1195504. Epub 2016 Jun 13.
PubMed 27294289Kouriefs C, Georgiou M, Ravi R. Hot flushes and prostate cancer: pathogenesis and treatment. BJU Int. 2002 Mar;89(4):379-83. doi: 10.1046/j.1464-4096.2001.01761.x. No abstract available.
PubMed 11872028Nishiyama T, Kanazawa S, Watanabe R, Terunuma M, Takahashi K. Influence of hot flashes on quality of life in patients with prostate cancer treated with androgen deprivation therapy. Int J Urol. 2004 Sep;11(9):735-41. doi: 10.1111/j.1442-2042.2004.00896.x.
PubMed 15379937Frisk J. Managing hot flushes in men after prostate cancer--a systematic review. Maturitas. 2010 Jan;65(1):15-22. doi: 10.1016/j.maturitas.2009.10.017. Epub 2009 Dec 4.
PubMed 19962840Trump DL. Commentary on "association of androgen deprivation therapy with cardiovascular death in patients with prostate cancer: a meta-analysis of randomized trials." Nguyen PL, Je Y, Schutz FA, Hoffman KE, Hu JC, Parekh A, Beckman JA, Choueiri TK, Department of Radiation Oncology, Dana-Farber Cancer Institute, Brigham and Women's Hospital, 75 Francis Street, Boston, MA 02115, USA: JAMA 2011;306(21):2359-66. Urol Oncol. 2012 Sep;30(5):746-7. doi: 10.1016/j.urolonc.2012.06.007. No abstract available.
PubMed 23021559Gavin AT, Donnelly D, Donnelly C, Drummond FJ, Morgan E, Gormley GJ, Sharp L. Effect of investigation intensity and treatment differences on prostate cancer survivor's physical symptoms, psychological well-being and health-related quality of life: a two country cross-sectional study. BMJ Open. 2016 Dec 19;6(12):e012952. doi: 10.1136/bmjopen-2016-012952.
PubMed 27993906Eziefula CU, Grunfeld EA, Hunter MS. 'You know I've joined your club... I'm the hot flush boy': a qualitative exploration of hot flushes and night sweats in men undergoing androgen deprivation therapy for prostate cancer. Psychooncology. 2013 Dec;22(12):2823-30. doi: 10.1002/pon.3355. Epub 2013 Jul 28.
PubMed 23893467
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Stellate Ganglion Blockade (SGB) in Men Treated for Prostate Cancer Improve Hot Flashes? A Pilot Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT03796195
- Acronym / sponsor ID
- STU00208657
- Conditions
- Prostate Cancer, Hot Flashes
- Keywords
- Stelate Ganglion Block
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Enrollment issues
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- 13 Nov 2019 (actual)
- Primary completion
- 16 Jul 2021 (actual)
- Study completion
- 16 Jul 2021 (actual)
- First posted
- 8 Jan 2019 (actual)
- Results
- Posted 25 Jan 2023
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 a critical component of advanced prostate cancer treatment but causes numerous adverse effects including decreased bone mass, decreased muscle mass, gynecomastia, erectile dysfunction, loss of sexual desire, depression, disordered sleep, urinary symptoms, and hot flashes (HF). HF are unpleasant paroxysmal episodes of flushing, sweating with vasodilation of the face, neck, and chest. These episodes can last for seconds to minutes and are often associated with night sweats, anxiety, and insomnia and have negative effects on quality of life.
Stellate ganglion blockade (SGB) with local anesthetic may be an effective treatment of HF in men on ADT, but has not been studied in any published clinical trials.
The stellate ganglion is a neural structure in the anterior cervical spine region and is part of the sympathetic nervous system. It has been injected safely in the practice of pain management for more than 50 years in cases of post herpetic neuralgia (shingles), complex regional pain syndrome (CRPS) and other painful neuropathies as well as some types of cardiac dysrhythmias.
Given the frequency and severity and interference of HF in men on ADT for prostate cancer, in addition to the negative effects HF impose on this patient population and a paucity of effective treatments, finding alternative treatments for HF in this population is needed.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| .5% Bupivacaine | Experimental | Drug: .5% BupivacaineGuided right sided stelate ganglion block using .5% bupivacaine (5mLs) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Men with prostate cancer (with or without metastatic disease) on ADT for at least 2 months
- Age less than 65 years
- Body Mass Index (BMI) less than 32
- Willingness to undergo image guided intervention
- Greater than 28 hot flashes per week.
Key exclusion criteria (4 listed)
- Conditions that preclude SGB or sham intervention (e.g., anatomic abnormalities of the anterior neck or cervical spine; metastatic disease in or near the cervical spine; goiter;cardiac/pulmonary compromise; sleep apnea; acute illness/infection; coagulopathy or bleeding disorder; allergic reactions/contraindications to a local anesthetic or contrast dye)
- Current treatment of prostate cancer with radium or chemotherapy
- Use of treatments in the past two months that can affect HF (e.g., testosterone or androgen supplementation) Note: SSRIs, serotonin norepinephrine uptake inhibitors, and membrane stabilizers will be allowed but must be on stable unchanged dose for at least 8 weeks)
- Inability to write, speak, or read in English
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 |
|---|---|---|
| .5% BupivacaineAlso: Right sided stelate ganglion block (SGB)Ultrasound guided right sided stelate ganglion block using .5% bupivacaine (5mLs) | Drug | .5% Bupivacaine |
Primary outcome
Hot Flash Frequency Change Baseline to 3 Months After Treatment.
Time frame: 3 months after SGB procedure
Change in mean daily hot flashes using a self-report hot flash diary from baseline to 3 months after stellate ganglion block.
3 secondary outcomes
Change in Hot Flash Severity Baseline to 3 Months After Stellate Ganglion Block
Time frame: 3 months after stellate ganglion block
PROMIS SF4a Score 4 Weeks After Stellate Ganglion Block.
Time frame: 4 weeks after stellate ganglion block
Patient Global Impression of Change Score (PGIC)
Time frame: 4 weeks after stellate ganglion block
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 29072790Gonzalez BD, Small BJ, Cases MG, Williams NL, Fishman MN, Jacobsen PB, Jim HSL. Sleep disturbance in men receiving androgen deprivation therapy for prostate cancer: The role of hot flashes and nocturia. Cancer. 2018 Feb 1;124(3):499-506. doi: 10.1002/cncr.31024. Epub 2017 Oct 26.
- Background: PubMed 28712786Dosani M, Morris WJ, Tyldesley S, Pickles T. The Relationship between Hot Flashes and Testosterone Recovery after 12 Months of Androgen Suppression for Men with Localised Prostate Cancer in the ASCENDE-RT Trial. Clin Oncol (R Coll Radiol). 2017 Oct;29(10):696-701. doi: 10.1016/j.clon.2017.06.009. Epub 2017 Jul 13.
- Background: PubMed 27294289Grunfeld EA, Hunter MS, Yousaf O. Men's experience of a guided self-help intervention for hot flushes associated with prostate cancer treatment. Psychol Health Med. 2017 Apr;22(4):425-433. doi: 10.1080/13548506.2016.1195504. Epub 2016 Jun 13.
- Background: PubMed 11872028Kouriefs C, Georgiou M, Ravi R. Hot flushes and prostate cancer: pathogenesis and treatment. BJU Int. 2002 Mar;89(4):379-83. doi: 10.1046/j.1464-4096.2001.01761.x. No abstract available.
- Background: PubMed 15379937Nishiyama T, Kanazawa S, Watanabe R, Terunuma M, Takahashi K. Influence of hot flashes on quality of life in patients with prostate cancer treated with androgen deprivation therapy. Int J Urol. 2004 Sep;11(9):735-41. doi: 10.1111/j.1442-2042.2004.00896.x.
- Background: PubMed 19962840Frisk J. Managing hot flushes in men after prostate cancer--a systematic review. Maturitas. 2010 Jan;65(1):15-22. doi: 10.1016/j.maturitas.2009.10.017. Epub 2009 Dec 4.
- Background: PubMed 23021559Trump DL. Commentary on "association of androgen deprivation therapy with cardiovascular death in patients with prostate cancer: a meta-analysis of randomized trials." Nguyen PL, Je Y, Schutz FA, Hoffman KE, Hu JC, Parekh A, Beckman JA, Choueiri TK, Department of Radiation Oncology, Dana-Farber Cancer Institute, Brigham and Women's Hospital, 75 Francis Street, Boston, MA 02115, USA: JAMA 2011;306(21):2359-66. Urol Oncol. 2012 Sep;30(5):746-7. doi: 10.1016/j.urolonc.2012.06.007. No abstract available.
- Background: PubMed 27993906Gavin AT, Donnelly D, Donnelly C, Drummond FJ, Morgan E, Gormley GJ, Sharp L. Effect of investigation intensity and treatment differences on prostate cancer survivor's physical symptoms, psychological well-being and health-related quality of life: a two country cross-sectional study. BMJ Open. 2016 Dec 19;6(12):e012952. doi: 10.1136/bmjopen-2016-012952.
- Background: PubMed 23893467Eziefula CU, Grunfeld EA, Hunter MS. 'You know I've joined your club... I'm the hot flush boy': a qualitative exploration of hot flushes and night sweats in men undergoing androgen deprivation therapy for prostate cancer. Psychooncology. 2013 Dec;22(12):2823-30. doi: 10.1002/pon.3355. Epub 2013 Jul 28.
- Individual participant dataSharing planned: No
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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.
David Walega, MD, MS principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing .5% Bupivacaine in people with Prostate Cancer and Hot Flashes, run by Northwestern University at 1 site in United States.
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 4 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: stopped early, as of the sponsor's last update on 25 Jan 2023. 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 United States. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Jan 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Flash Frequency Change Baseline to 3 Months After Treatment. (time frame: 3 months after SGB procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03796195, which also lists 9 linked publications.
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 25 Jan 2023.