(SGB) in Men Treated for Prostate Cancer Improve Hot Flashes

Study Overview
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Brief Summary
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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.

Official Title
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Does Stellate Ganglion Blockade (SGB) in Men Treated for Prostate Cancer Improve Hot Flashes? A Pilot Prospective Cohort Study

Conditions
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Prostate Cancer, Hot Flashes

Intervention / Treatment
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* Drug: .5% Bupivacaine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: .5% Bupivacaine<br>Guided right sided stelate ganglion block using .5% bupivacaine (5mLs) | Drug: .5% Bupivacaine<br>* Ultrasound guided right sided stelate ganglion block using .5% bupivacaine (5mLs)<br>* Other names: Right sided stelate ganglion block (SGB);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 3 months after SGB procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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). | 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). | 4 weeks after stellate ganglion block | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stelate Ganglion Block