Does Stellate Ganglion Blockade (SGB) in Men Treated for Prostate Cancer Improve Hot Flashes? A Pilot Prospective Cohort Study
Phase: PHASE4
Conditions: Prostate Cancer, Hot Flashes
Sponsor: Northwestern University

Study Tittle: Does Stellate Ganglion Blockade (SGB) in Men Treated for 
Prostate Cancer Improve Hot Flashes? A Pilot Prospective Cohort Study
Study Protocol Version 3.1 11/25 2019
NCT003796195 

STU#:00208657 
Version 3.1 
 11/25/2019
D. Walega, MD STU00208657
V 3.1 11/25/2019
Page 1 of 21
PROTOCOL TITLE:  Does Stellate Ganglion Blockade (SGB) in Men Treated for Prostate Cancer
 Improve Hot Flashes?  A Pilot Prospective Cohort Study 
PRINCIPAL INVESTIGATOR:
David Walega, MD, MSCI
Department of Anesthesiology
312-927-1345
d-walega@northwestern.edu
Co-Investigator
Alicia Morgans, MD, MPH
Department of Medicine, Division of Hematology & Oncology
Statistician
Michael Avram, PhD
Department of Anesthesiology
VERSION NUMBER:
3.1
VERSION DATE:
11/25/2019
STUDY SUMMARY:
Special Population(s)
NA 
Sample Size
N = 14  is the required number of enrollees who are 
needed to be evaluable both at baseline and 6 months 
for the primary outcome. Allowing for dropouts, up to 18 
pts might be enrolled
Funding Source
Internal funding
type of consent to be 
obtained
Written 
Site
Single Site 
Research Related 
Radiation Exposure
Yes 
IRB #: STU00208657 Approved by NU IRB for use on or after 9/16/2020 through 8/30/2021.

STU#:00208657 
Version 3.1 
 11/25/2019
D. Walega, MD STU00208657
V 3.1 11/25/2019
Page 2 of 21
1.0
OBJECTIVES:
Scope:  Men with prostate cancer with or without metastatic disease treated with androgen 
deprivation therapy for at least 2 months, with bothersome refractory hot flashes, will be 
enrolled as participants in this open label clinical trial.  
Aim 1: To determine the effect of stellate ganglion blockade (SGB) for reducing hot flash 
frequency and severity in men with prostate cancer in the 6 months following the intervention.
                              
Aim 2: To evaluate the effect of SGB on daily hot flash (HF) interference and sleep quality.
Hypotheses:  Hot flash frequency, interference and sleep quality will be improved in men 
following stellate ganglion blockade with local anesthetic.
2.0
BACKGROUND:
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)(1). 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 (9). 
Although the exact mechanism of HF is unclear, HF in men on ADT appear related to 
decreased androgen exposure (1-5). Studies confirm that 50-93% of men who receive ADT 
report HF (1, 3, 6). These symptoms are typically long lasting. They start within two months 
of ADT initiation and persist 6 months to several years after ADT discontinuation (7).  One 
recent study showed that 27% of men on ADT reported HF as their most distressing side 
effect of prostate cancer treatment (8). There is considerable psychological distress 
associated with poorly controlled HF in men (9, 10) that has a negative impact on mental 
health, including feelings of decreased masculinity and the sense that one’s traditional 
gender role is diminished.  Together, these factors compound the psychological, 
psychosocial and psychosexual stresses of prostate cancer survivorship. 
Younger and leaner men typically have more frequent and severe HF from ADT when 
compared to other groups, and several genetic polymorphisms are associated with a high 
rate of hot flashes in men on ADT, specifically, those that effect immune function, 
neurotransmission, vasoconstriction, and circadian rhythms (11).  Because of the numerous 
negative effects of HF on QOL, sleep, and sexuality, HF can make patients less likely to 
begin hormonal therapy and can lead to the early discontinuation of ADT (7, 12) or poor 
treatment adherence (13).
Few trials have been done assessing treatment of HF in men with prostate cancer, and those 
that have been published typically show lackluster or inconsistent outcomes or an 
unacceptable side effect profile (6, 13-16). Testosterone supplementation is obviously 
contraindicated.  
IRB #: STU00208657 Approved by NU IRB for use on or after 9/16/2020 through 8/30/2021.

STU#:00208657 
Version 3.1 
 11/25/2019
D. Walega, MD STU00208657
V 3.1 11/25/2019
Page 3 of 21
In women, pharmacological treatments (anti-depressants, anti-epileptics, anti-hypertensives), 
physical/behavioral treatments (e.g., acupuncture, yoga/exercise, relaxation techniques, 
cognitive behavioral therapy), and natural health products (e.g., black cohosh, flax, vitamin E, 
ginseng) have been studied for control of HF, but most have not been critically evaluated by 
clinical trials in men (17-19).  Most medications shown to mitigate HF have their own unique 
side effects, or require daily compliance to maintain consistent efficacy.  
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. We 
recently published a prospective, randomized, sham controlled study of SGB in women with 
natural or surgical menopause, in which we found a 52% decrease in moderate to very 
severe HF in women who underwent a single SGB with bupivacaine, a local anesthetic, as 
compared to a13% decrease in women in the sham control group who underwent an injection 
of saline. (20). 
Another controlled study of SGB in women with breast cancer on endocrine therapy 
confirmed considerable reductions in frequency and intensity of HF in patients who had SGB 
(21). Uncontrolled studies of women with breast cancer and heterogeneous populations 
including postmenopausal women have demonstrated improvements in the frequency and 
intensity of HF following SGB, with 45-90% reduction in HF frequency or intensity, for 
durations ranging from 4 weeks to several months (22-24). Together, this literature provides 
further support of the hypothesis that SGB could be beneficial to men on ADT.  
The mechanism of SGB mitigation of HF in men is unclear. The effects of testosterone on 
prevertebral ganglia are widely variable (25). Anatomic connections between the stellate 
ganglion and thermoregulatory regions in the brain via third order neurons have been 
described (26). SGB interrupts the sympathetic nervous system and may modulate 
norepinephrine levels in these thermoregulatory regions.  Androgen deprivation as in ADT 
appears to change NE levels and activate the sympathetic nervous system in rat models 
(27), but the detailed interaction between testosterone and NE levels in humans is unclear 
(25, 28, 29). Some authors have alternatively hypothesized that Nerve Growth Factor (NGF) 
levels are modulated following SGB (30, 31), and there is evidence that NGF levels may 
decrease with testosterone withdrawal, affecting neural growth and neural plasticity (32, 33) 
that could ultimately effect thermoregulation. 
We are currently studying SGB effects in postmenopausal women in a sham-controlled 
clinical trial funded by the National Institute on Aging (NIA R01AG049924-01; PI Walega).  
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.  
IRB #: STU00208657 Approved by NU IRB for use on or after 9/16/2020 through 8/30/2021.

STU#:00208657 
Version 3.1 
 11/25/2019
D. Walega, MD STU00208657
V 3.1 11/25/2019
Page 4 of 21
3.0
STUDY ENDPOINTS:
Primary Outcome 
Change in frequency of weekly hot flashes by self-report hot flash diary between baseline 
and 3 months following the intervention. 
Secondary Outcomes
1.
Change in frequency of weekly hot flashes by self-report hot flash diary between baseline 
and 1 month following the intervention. 
2.
Change in frequency of weekly hot flashes by self-report hot flash diary between baseline 
and 6 months following the intervention. 
3.
the change in hot flash severity (hot flash frequency * hot flash intensity) between 
baseline and 1, 3, 6 months following the intervention
4.
the change in Hot Flash Related Daily Interference Scale (HFRDIS) between baseline 
and 1, 3, 6 months following the intervention
5.
PROMIS SF4a (sleep)
6.
Patient Global Impression of Change Score (PGIC)
7.
Number and type of adverse events related to SGB according to NCI-CTCAE v5.0.
Mean frequency= ((Fmo+Fse))/7
where Fmi, Fmo and Fse are the weekly total number of mild, moderate or severe/very 
severe HF events
Mean severity =  (Fmi+2×Fmo+3×Fse)/7
where Fmi, Fmo and Fse are the weekly total number of mild, moderate or severe/very 
severe HF events In the case of mean severity, frequency of mild vasomotor symptoms 
(VMS) is not counted at baseline
4.0
STUDY INTERVENTION:
Image Guided Right Sided Stellate Ganglion Block with 0.5% Bupivacaine 
5.0
PROCEDURES INVOLVED:
5.1
Study design: 
We aim to conduct a single-site, open label trial of SGB in men with prostate cancer 
on ADT. 
5.2
Methods & Study Procedures:
Refer to the Section 5.3, Schedule of Events, for additional information.
Visit 1
Consent
After participants have reviewed and signed the consent form in person, they will be 
interviewed to determine candidacy for the study. They will be asked to provide information 
about themselves and their medical history. Participants will consult with Dr. Walega who 
will explain the injection procedure and perform a brief physical examination (focus on 
cervical range of motion and anterior cervical anatomy) to confirm patient eligibility for the 
IRB #: STU00208657 Approved by NU IRB for use on or after 9/16/2020 through 8/30/2021.

STU#:00208657 
Version 3.1 
 11/25/2019
D. Walega, MD STU00208657
V 3.1 11/25/2019
Page 5 of 21
study. The SGB will be scheduled within 2 weeks of this visit, based on convenience and 
availability of the participant. Participants will be asked to complete a Hot Flash Related 
Daily Interference Scale and secondary outcome measures at this visit. They will complete a 
hot flash diary for at least 1 week. To qualify for study inclusion, participants must have > 28 
hot flashes per week or will be considered a screen failure and will be excluded.
Visit 2
Intervention
Participants will be NPO for 6 hours prior to the intervention and will arrange transportation 
home.  At the time of the injection procedure, an angiocatheter will be placed in the 
hand/arm for peripheral intravenous access as a safety precaution. Participants will be 
positioned supine in cervical extension on a procedure table in the fluoroscopy suite of the 
NMH Pain Clinic (Lavin 1400). The anterior neck will be prepped with chlorhexidine and 
draped in the standard sterile manner. 
A right-sided SGB will be performed. Using fluoroscopic guidance, the C6 vertebra will be 
identified and the skin overlying the tubercle will be anesthetized using 2 mL of 1% 
lidocaine. Using digital pressure to laterally retract the carotid artery, a 22 g 1.5-inch needle 
will be placed to make contact with the anterolateral portion of the C6 vertebra and then 
retracted 1-2 mm and secured; contrast material (iopamidol 1-2 mL) will be injected with 
fluoroscopic guidance to confirm contrast dye spread in the prevertebral fascial plane and to 
rule out intravascular or intrathecal dye spread. 0.5% bupivacaine (5 mL) will be injected 
and the needle will be removed. 
Monitoring after SGB
Participants will be transferred to a recovery area and monitored in a reclining position for 
approximately 20-30 minutes after the SGB to assess potential adverse effects of the 
injection. Vital signs will be measured approximately every 5 minutes during the recovery 
phase. Presence of a Horner’s sign (miosis, ptosis, anhydrosis) will be recorded and will 
validate successful SGB. Expected adverse events and serious adverse events may include 
any of the following:
Adverse Events (Immediate Post-Procedure):
Local anesthetic toxicity (seizure, loss of consciousness)
Inability to swallow (superior laryngeal nerve spread of local anesthetic)
Difficulty with phonation (recurrent laryngeal nerve spread of local anesthetic)
Weakness of arm (brachial plexus spread of local anesthetic)
Weakness of arms and legs (epidural spread of local anesthetic)
Shortness of breath (phrenic nerve spread of local anesthetic)
These effects would be clinically apparent in the Post-Anesthesia Care Unit (PACU) during 
the 30 minute post injection observation period; patients are not discharged until vital signs, 
motor and sensory function of the upper and lower extremities are assessed as normal, and 
patient is able to phonate and swallow liquids.
IRB #: STU00208657 Approved by NU IRB for use on or after 9/16/2020 through 8/30/2021.

STU#:00208657 
Version 3.1 
 11/25/2019
D. Walega, MD STU00208657
V 3.1 11/25/2019
Page 6 of 21
Follow-Up

24h follow-up (+3 days to allow for scheduling constraints with weekends)
Participants will be contacted one day following the intervention to assess for any adverse 
events or side effects.  Expected adverse events may include any of the following: 
Pain at injection site
Swelling at injection site
Severe bruising at injection site

Long-term follow-up at 1, 3, and 6 months
Participants will complete daily hot flash diaries and weekly HFRDIS scales via REDcap 
email for the duration of the 6 month follow up. Secondary measures will be collected at 1, 3 
and 6 months after the intervention. Participants will have the opportunity to share any new 
concerns or problems with research personnel during these interactions, and will be 
instructed to contact Dr. Walega (PI) if any more urgent concerns arise.  Contact information 
is provided in the ICF.
Patients will be contacted via telephone or via REDcap generated email on a weekly basis, 
if needed, to encourage continued participation in follow up measures, and data will be 
collected via REDcap. Reminder phone calls will be made if the participant forgets to send 
their information.
Schedule of Events
IRB #: STU00208657 Approved by NU IRB for use on or after 9/16/2020 through 8/30/2021.

STU#:00208657 
Version 3.1 
 11/25/2019
D. Walega, MD STU00208657
V 3.1 11/25/2019
Page 7 of 21
1. Demographic information and medical history to include: age, body mass index, race, years 
of education, marital status, Gleason score, duration of hot flashes (months), type of ADT 
(specify) per Section 5.4.  Height and weight to be collected for BMI calculation. Pathology 
report to be collected to determine Gleason Score. 
2. Brief physician-directed physical exam to focus on cervical range of motion and anterior 
cervical anatomy per Section 5.2.
3. Refer to Section 5.6 for details on the collection of AEs and SAEs. In brief, AEs that are 
related to the intervention (irrespective of expectedness) will be collected from the time of 
consent (baseline) through the 30 days after the intervention (the 1 month follow-up visit). 
All SAEs (irrespective of attribution/relatedness or expectedness) will be collected from the 
time of consent (baseline) through 30 days after the intervention (the 1 month follow-up 
visit). 
4. Screening labs not required for this study; not a standard of care 
5. Patient-reported hot flash (HF) frequency and HF intensity to be collected, based on the 
participant’s hot flash diary.  These values will be used to calculate a HF severity score, per 
Section 3.0. Participants must complete the diary for at least 1 week prior to receipt of the 
intervention to be able to determine the baseline HF severity score.  
6. HFRDIS, PROMIS SF4a, and PGIC score questionnaires to be administered via REDCap.  
Other methods may also be used (i.e. in person, over the phone, through mail or email, 
etc.) if required.
7. All screening assessments to be conducted 0-14 days prior to registration, unless 
otherwise indicated. Participants must register to the trial prior to receipt of the study 
intervention. Refer to Section 12.0 for registration instructions. 
8. The SGB intervention should take place AFTER registration and within 1-2 weeks after the 
baseline/screening assessments per Section 5.2. Participants are to complete the diary 
daily starting at least 1 week prior to receipt of the SGB intervention. Details of the SGB 
intervention and Horner’s sign assessment are described in Section 5.2
9. Vitals are to be assessed approximately every 5 minutes for approximately 20-30 minutes 
while participants are in recovery, after receipt of SGB. 
10. Participants will be contacted for follow-up via their preferred method of contact (phone call, 
in-person visit, email, etc.) 1 day and 1 month after the intervention to collect AE/SAE data.  
They will also be contacted (via REDcap or other means) at 1 month, 3 months, and 6 
months to collect information for secondary outcomes. 
11. Qualified research staff may contact participants via their preferred method of contact 
(phone call, in-person visit, email, REDcap generated email, etc.) approximately once a 
week (or less frequently as needed) throughout the course of the study to remind 
participants to comply with study procedures, including but not limited to: scheduling 
appointments; completing the HF diary; completing the HFRDIS, PROMIS SF4a, and PGIC 
score questionnaires; assessing AEs/SAEs. 
12. Participants will be instructed to begin completing the hot flash diary at the time of 
screening/baseline assessments.  Participants are to complete the diary daily starting at 
least 1 week prior to receipt of the SGB intervention and through the 6-month follow-up 
time point. Weekly phone calls (or other preferred method of contact) may be used to 
remind participants to comply.
IRB #: STU00208657 Approved by NU IRB for use on or after 9/16/2020 through 8/30/2021.

STU#:00208657 
Version 3.1 
 11/25/2019
D. Walega, MD STU00208657
V 3.1 11/25/2019
Page 8 of 21
5.4
Outcome Measures
Hot Flash Diary
Daily Hot Flash Diaries (daily throughout entire study): daily diaries include 
measures of: (a) hot flashes frequency while awake; (b) the number of night 
sweats; (c) intensity of hot flashes while awake, with 
0 = none
1 = mild (1 or 2 episodes of heat)
2 = moderate (3 to 4 episodes of heat with discrete sweating)
3 = severe (5 or more sudden episodes of heat accompanied by sweating, sleep 
disturbance, feelings of irritation or anxiety).
Hot Flash Related Daily Interference Scale (HFRDIS)(34)
This validated measure assesses the impact of hot flashes on overall quality of 
life as well as on work, social activities, leisure activities, sleep, mood, 
concentration, relations with others, sexuality, and enjoyment of life. A total of 10 
areas are assessed with a 0-10 scale. The maximum score, demonstrating the 
most severe interference of HF is 100.
PROMIS SF4a (sleep)
One of the PROMIS measures, this is a 4-item questionnaire that queries sleep 
duration, quality, and interruption. 
Patient Global Impression of Change
This outcome has the participant assess how much improvement they believe 
they have experienced from an intervention.  This will be collected at 1, 3, and 6 
month time points.
General Demographic and Health Status Information
We will obtain sociodemographic and clinical variables based on participant 
report, including
age
body mass index
race
years of education 
marital status
Gleason score
duration of hot flashes (months)
type of ADT (specify)
5.5
SGB Risks & Safety:
Stellate ganglion injections are commonly performed in the U.S., have been in 
clinical use for more than 50 years, and are considered safe and effective in 
treating a variety of neuropathic syndromes and ischemic pain states and cardiac 
dysrhythmias (Complex Regional Pain Syndrome Type I and II, herpes zoster, 
frostbite, Raynaud’s syndrome, vascular headaches, refractory ventricular 
tachycardia, pulmonary artery hypertension, for example). Several more recent 
studies have demonstrated clinical effectiveness in treating vasomotor symptoms 
IRB #: STU00208657 Approved by NU IRB for use on or after 9/16/2020 through 8/30/2021.

STU#:00208657 
Version 3.1 
 11/25/2019
D. Walega, MD STU00208657
V 3.1 11/25/2019
Page 9 of 21
in women and no adverse events have been reported from these more recent 
trials.  
SGB is considered safe when performed with image guidance and by an 
experienced injectionist. The published rate of adverse events with SGB, pre-
dating image guided procedures, is 0.17%.   Severe injury related to SGB is very 
rare. The incidence of unanticipated bleeding complications following SGB is 
1:100,000. It follows that image guided injections, as with fluoroscopy, would 
have far fewer complications, as critical vascular or neural structures can be 
visualized in real time and thus can be avoided. Dr. Walega has been performing 
this injection for 20 years and has 3 other active clinical trials assessing the 
effects of SGB in women, including a study funded by the National Institute on 
Aging, of which Dr. Walega is the PI.  
In none of these studies has an adverse event occurred. Adverse events will be 
assessed at the time of the study intervention, at discharge from the post-
anesthesia care unit (PACU), at the 24 hour post-injection follow-up, and at the 1 
month follow-up. All adverse events that are possibly, probably, or definitely 
related to the intervention will be collected. All SAEs, regardless of attribution, will 
be collected.  Refer to Section 5.6 for details. 
The following potential adverse events are expected: 
Risks of Stellate Ganglion Injection
Stellate ganglion injection carries the potential risk of infection, bleeding, 
transient seizure, or nerve injury which may result in paresthesia or weakness. 
Risks are mitigated and effectively minimized with the use of fluoroscopic 
guidance and confirmatory contrast dye study during the SGB. 
Risks Related to Needle Placement
Temporary bruising or swelling at the site of the injection on the right anterior 
neck
Hematoma (pocket of blood caused by bleeding from a broken blood vessel)
Injury to the nerves around the injection site
Puncture of the lung or a blood vessel which may compress the lung and require 
further medical treatment.
Infection of the tissues of the neck, nerves, bone or disc material in the area of 
injection
Risks Related to spread of local anesthetic
Allergic reaction to local anesthetics (lidocaine or bupivacaine) or contrast dye
Temporary voice hoarseness
Temporary difficulty swallowing
Temporary weakness of the right diaphragm which may cause shortness of 
breath or mild difficulty in breathing
Temporary high or low blood pressure
Temporary numbness on the anterior neck region and right shoulder
Temporary numbness or weakness of the arms and legs with short term inability 
to talk or swallow
IRB #: STU00208657 Approved by NU IRB for use on or after 9/16/2020 through 8/30/2021.

STU#:00208657 
Version 3.1 
 11/25/2019
D. Walega, MD STU00208657
V 3.1 11/25/2019
Page 10 of 21
*As the half-life of bupivacaine is 6-8 hours, all of the above would resolve within 
this 6-8 hour time period
*Antidotes to local anesthetic toxicity, including propofol and lipid emulsion, are 
immediately available in the Omnicell of the Pain Clinic
*A crash cart is immediately available in the recovery room of the Pain Clinic
*The Pain Clinic is staffed by 3 anesthesiologists daily, in addition to 2-3 RNs
Risks Related to Fluoroscopy
The dose of radiation used in the procedure is approximately equal to 25 days of 
natural environmental radiation the average person receives in the United States.
Radiation Dosimetry Form 
5.6
Adverse Events (AE) and Serious Adverse Events (SAE)
This study will be conducted in compliance with the Data Safety Monitoring Plan 
(DSMP) of the Robert H. Lurie Comprehensive Cancer Center of Northwestern 
University. The level of risk attributed to this study requires moderate intensity 
monitoring, as outlined in the DSMP. All SAEs will be reported in real time to 
Northwestern University’s Quality Assurance (QA) Dept. and the Northwestern 
IRB. All AEs that are possibly, probably, or definitely related to the intervention 
will be reported to Northwestern University’s QA Dept. on a semi-annual basis.  
In addition, the study will abide by all safety reporting regulations, as set forth in 
the Code of Federal Regulations.  
5.6.1
Adverse Event Monitoring & Reporting
Adverse event data collection and reporting, which are required as part of 
every clinical trial, are done to ensure the safety of subjects enrolled in 
the studies as well as those who will enroll in future studies using similar 
agents. Adverse events are reported in a routine manner at scheduled 
times during a trial (see Sections 5.2 and 5.3 for time points). In addition, 
certain adverse events must be reported in an expedited manner to allow 
for optimal monitoring and patient safety and care. 
5.6.2 Definitions & Descriptions
5.6.2.1    Adverse Events
An adverse event (AE) is any untoward medical occurrence in a 
patient receiving study treatment and which does not necessarily 
have a causal relationship with this treatment. An AE can 
therefore be any unfavorable and unintended sign (including an 
abnormal laboratory finding), symptom, or disease temporally 
associated with the use of an experimental intervention, whether 
or not related to the intervention. 
Recording of AEs should be done in a concise manner using 
standard, acceptable medical terms. In general, AEs are not 
procedures or measurements, but should reflect the reason for 
the procedure or the diagnosis based on the abnormal 
measurement. Preexisting conditions that worsen in severity or 
IRB #: STU00208657 Approved by NU IRB for use on or after 9/16/2020 through 8/30/2021.

STU#:00208657 
Version 3.1 
 11/25/2019
D. Walega, MD STU00208657
V 3.1 11/25/2019
Page 11 of 21
frequency during the study should also be recorded (a 
preexisting condition that does not worsen is not an AE). 
Further, a procedure or surgery is not an AE; rather, the event 
leading to the procedure or surgery is considered an AE.
If a specific medical diagnosis has been made, that diagnosis or 
syndrome should be recorded as the AE whenever possible.  
However, a complete description of the signs, symptoms and 
investigations which led to the diagnosis should be provided. For 
example, if clinically significant elevations of liver function tests 
are known to be secondary to hepatitis, “hepatitis” and not 
“elevated liver function tests” should be recorded. If the cause is 
not known, the abnormal test or finding should be recorded as 
an AE, using appropriate medical terminology (e/g/ 
thrombocytopenia, peripheral edema, QT prolongation).
For this study, only AEs that are possibly, probably, or 
definitely related to the intervention will be collected (Refer 
to Section 5.6.2.3 for separate criteria for collection of SAEs).  
Expected symptoms are listed in Sections 5.2 and 5.5 and/or 
can be found in the U.S. FDA drug package insert. AEs that are 
possibly, probably, or definitely related to the intervention will be 
collected from the time of signing informed consent until 30 days 
after receipt of the intervention at the 1 month follow-up time 
point. Refer to Sections 5.2 and 5.3 for additional information on 
the time points for AE collection. 
5.6.2.2    Severity of Adverse Events
All adverse events will be graded according to the NCI Common 
Terminology Criteria for Adverse Events (CTCAE) version 5.0. 
The CTCAE v5.0 is available at 
https://ctep.cancer.gov/protocoldevelopment/electronic_applicati
ons/ctc.htm
If no CTCAE grading is available, the severity of an AE is graded 
as follows:
• Mild (grade 1): the event causes discomfort without disruption 
of normal daily activities.
• Moderate (grade 2): the event causes discomfort that affects 
normal daily activities.
• Severe (grade 3): the event makes the patient unable to 
perform normal daily activities or significantly affects his/her 
clinical status.
• Life-threatening (grade 4): the patient was at risk of death at 
the time of the event.
• Fatal (grade 5): the event caused death.
IRB #: STU00208657 Approved by NU IRB for use on or after 9/16/2020 through 8/30/2021.

STU#:00208657 
Version 3.1 
 11/25/2019
D. Walega, MD STU00208657
V 3.1 11/25/2019
Page 12 of 21
5.6.2.3    Serious Adverse Events
All serious adverse events (SAEs), regardless of expectedness 
and attribution, occurring from the time of signed informed 
consent, through 30 days after the last administration of study 
drug (i.e. at the 1 month follow-up time point), must be reported 
upon discovery or occurrence. 
An SAE is defined in regulatory terminology as any untoward 
medical occurrence that:
•
Results in death.
•
Is life-threatening.
The patient was at risk of death at the time of the event; it 
does not refer to an event that hypothetically might have 
caused death if it were more severe.
•
Requires in-patient hospitalization or prolongation of 
existing hospitalization for ≥ 24 hours.
•
Results in persistent or significant disability or incapacity.
•
Is a congenital anomaly/birth defect.
•
Is an important medical event.
Any event that does not meet the above criteria, but that in 
the judgment of the investigator jeopardizes the patient, may 
be considered for reporting as a serious adverse event. The 
event may require medical or surgical intervention to prevent 
one of the outcomes listed in the definition of “Serious 
Adverse Event“. For example: allergic bronchospasm 
requiring intensive treatment in an emergency room or at 
home; convulsions that may not result in hospitalization; 
development of drug abuse or drug dependency.
5.6.2.4    Unanticipated Problems Involving Risks to Subjects or 
Others (UPIRSO)
A UPIRSO is a type of SAE that includes events that meet ALL 
of the following criteria:
Is unanticipated in terms of nature, severity, or frequency
Places the research subject or others at a different or greater 
risk of harm
Is deemed to be at least possibly related to participation in 
the study.   
5.6.2.5    Expedited Reporting to Northwestern University’s 
QAM/DMC
All SAEs must be reported to the assigned QAM within 24 hours 
of becoming aware of the event. Completion of the NU CRO 
SAE Form, provided as a separate document, is required.
The completed form should assess whether or not the event 
qualifies as a UPIRSO. The report should also include:

Protocol description and number(s)

The patient’s identification number
IRB #: STU00208657 Approved by NU IRB for use on or after 9/16/2020 through 8/30/2021.

STU#:00208657 
Version 3.1 
 11/25/2019
D. Walega, MD STU00208657
V 3.1 11/25/2019
Page 13 of 21

A description of the event, severity, treatment, and 
outcome (if known)

Supportive laboratory results and diagnostics

The hospital discharge summary (if available/applicable)
All SAEs will be reported to and reviewed by the DMC at their 
next meeting.
5.6.2.6    Expedited Reporting to Northwestern University’s IRB
Any death of an NU subject that is unanticipated in nature 
and at least possibly related to study participation will be 
promptly reported to the NU IRB within 24 hours of 
notification. 
Any death of an NU subject that is actively on study treatment 
(regardless of whether or not the event is possibly related to 
study treatment)
Any death of a non-NU subject that is unanticipated and at 
least possibly related and any other UPIRSOs will be reported 
to the NU IRB within 5 working days of notification.
All other deaths of NU subjects not previously reported, other 
non-NU subject deaths that were unanticipated and 
unrelated, and any other SAEs that were not previously 
reported as UPIRSOs will be reported to the NU IRB at the 
time of annual continuing review.
5.6.2.7    Routine Reporting to Northwestern University’s QAM/DMC
All routine AEs (those that are possibly, probably, or definitely 
related to the intervention) must be reported to the assigned 
QAM on a semi-annual basis. 
6.0
DATA AND SPECIMEN BANKING 
NA
7.0
SHARING RESULTS WITH PARTICIPANTS
Specific or detailed study results will not be shared with the study participants 
8.0
STUDY TIMELINES
IRB submission and approval process 1 month
Recruitment 6 months
Participant follow-up 6 months
Statistical analysis and Manuscript development 2 months
Duration of participation for each subject is approximately 6.5 months
IRB #: STU00208657 Approved by NU IRB for use on or after 9/16/2020 through 8/30/2021.

STU#:00208657 
Version 3.1 
 11/25/2019
D. Walega, MD STU00208657
V 3.1 11/25/2019
Page 14 of 21
9.0
INCLUSION AND EXCLUSION CRITERIA
Inclusion criteria:
1.
Men with prostate cancer (with or without metastatic disease) on ADT for at least 2 
months
2.
Must have greater than 28 hot flashes per week
3.
Age ≥18 years and less than ≤ 70  years 
4.
Body Mass Index (BMI) less than 32
5.
Willingness to undergo image guided intervention
6.
Must have the ability to understand and the willingness to sign a written informed 
consent prior to registration on study
Exclusion criteria:
1.
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 history of bleeding disorder; allergic reactions/contraindications to 
a local anesthetic or contrast dye)
2.
Current treatment of prostate cancer with radium or chemotherapy at the time of 
registration, or within ≤ 14 days prior to the date of SGB intervention. 
3.
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 prior to 
registration.
4.
Inability to write, speak, or read in English
5.
Any other illness or condition that the treating investigator feels would interfere with 
study compliance or would compromise the patient’s safety or study endpoints
10.0
VULNERABLE POPULATIONS 
NA
11.0
PARTICIPANT POPULATION
Accrual 
Number:
Category/Group:
Adults
Consented:
Maximum Number to be 
Consented or 
Reviewed/Collected/Screened
Enrolled:
Number to Complete 
the Study or Needed 
to Address the 
Research Question
Total:
18
18
14
IRB #: STU00208657 Approved by NU IRB for use on or after 9/16/2020 through 8/30/2021.

STU#:00208657 
Version 3.1 
 11/25/2019
D. Walega, MD STU00208657
V 3.1 11/25/2019
Page 15 of 21
12.0
RECRUITMENT METHODS & REGISTRATION
12.1
Recruitment Methods
Participants will be recruited from Dr. Morgans’ practice in addition to other 
prostate cancer oncologists and caregivers in the NM Division of Hematology & 
Oncology. Participants will call the study team to go through the 10 minute 
screening survey. This includes a baseline HFRDIS questionnaire to ensure the 
patient would qualify. The participant needs to have a score of >40 to be eligible 
for the study. Once it is determined they meet the criteria for the HFRDIS 
subjects will be asked to come to the research office for consenting if they are 
interested in the study. 
Flyers will be posted around the NMH medical center to advertise the study. 
The trial will be posted on clinical trials.gov
12.2
Registration Procedures
For potential patients for this study, study teams are asked to inform the 
Quality Assurance Monitor (QAM) of the date and time that the patient will need 
to be registered (croqualityassurance@northwestern.edu).  
BEFORE a patient can be treated on study, please complete and submit the 
following items to confirm eligibility and receive a subject identification number: 
• Eligibility eCRF (complete in NOTIS at https://notis.fsm.northwestern.edu) 
• Eligibility checklist (signed and dated by the treating physician – upload in 
NOTIS)
• Signed and dated informed consent document (upload in NOTIS) 
The QAM will review the above registration materials, register the patient, assign 
an identification number, and send a confirmation of registration to involved 
personnel. Registration will then be complete and the patient may begin study 
treatment.
13.0
COMPENSATION FOR PARTICIPATION IN RESEARCH ACTIVITIES
Participants will receive $100 by check mailed to their address at the completion of the 
study to compensate for their time and effort in this study. They will receive parking 
passes for the on-site study visits.
14.0   WITHDRAWAL OF PARTICIPANTS
Patients can be taken off the study treatment and/or the study as a whole at any time at 
their own request, or they may be withdrawn at the discretion of the investigator for 
safety, behavioral or administrative reasons. The reason(s) for discontinuation must be 
clearly documented on the appropriate CRF.  An example of when participants may be 
withdrawn from the research without their consent is if they are non-compliant with 
providing outcome measures and/or if they begin using a medication known to have an 
effect on HF. In such cases, or if the participant communicates in writing that he wishes to 
withdraw, this will be communicated to the study team and the participant and status will 
be changed from “active” to “inactive”. 
IRB #: STU00208657 Approved by NU IRB for use on or after 9/16/2020 through 8/30/2021.

STU#:00208657 
Version 3.1 
 11/25/2019
D. Walega, MD STU00208657
V 3.1 11/25/2019
Page 16 of 21
15.0
RISKS TO PARTICIPANTS
See “Risks & Safety” in PROCEDURES above
16.0
POTENTIAL BENEFITS TO PARTICIPANTS
Individual participants may experience an improvement in hot flashes as a result of this 
research, with secondary improvements in quality of life, mood and sleep. 
17.0
STATISTICS, DATA MANAGEMENT AND CONFIDENTIALITY
Power Analysis
We derived our sample size estimates for the analysis of the primary endpoint for this 
study, i.e., change in weekly frequency of severe hot flashes at 6 months post-
intervention vs. baseline (pre-intervention), based on data in the literature from a 
randomized controlled trial comparing different treatments for HF in men with prostate 
cancer on ADT. The pre-treatment baseline weekly frequency of severe hot flashes was 
assumed to be 46.0 ± 43 (mean ± SD)35. 
Because there are no published data on the variability of within-person differences 
between the 6-month and baseline measures for severe hot flashes, we estimated the 
variance for this 6-month change variable using the equation for the variance of the 
difference between two possibly correlated measurements, as provided in the textbook by 
Rosner, 7th edition, pg. 305.  This equation depends on the baseline standard deviation 
(SD1), the standard deviation of the 6-month assessment (SD2), and the within-person 
correlation (ρ) between the baseline and 6 month follow-up variables.  We allowed the 
original baseline and 6-month SDs to differ at the two assessment times but varied the 
within-person correlation between pre- and 6-month post-treatment measurements 
(range: ρ =0.5 to ρ=0.8, in increments of 0.1). 
The results below assumed a value of 21 for SD2 and assume the properties of the 
exponential distribution are approximately valid for the severe hot flashes measure (i.e., 
we assumed that the underlying mean and standard deviation are approximately equal).
Using a paired one-sample t-test comparing changes between 6-month assessment and 
baseline, a sample size of 14 participants will provide 80% power with a two-sided α = 
0.05 to detect a reduction of 52% in mean frequency of severe hot flashes (Δ=23.9) if 
ρ=0.8 (e.g., from a mean of 46.0 at baseline to 22.1 at 6-months following treatment)20.  
As an exploratory calculation, if our assumptions were revised to ρ=0.7, then the 
corresponding sample size required would be 17 participants. 
If we expect up to about 20% attrition in studies such as this, then we will recruit up to a 
total of 18 participants in this pilot study.
Statistical Plan
Nominal patient characteristics data will be summarized descriptively as number and 
percent of participants in each category. Ordinal and continuous patient data that are not 
approximately normally distributed will be summarized as median and interquartile range 
(IQR). Normally distributed continuous patient data will be presented as mean ± SD.
IRB #: STU00208657 Approved by NU IRB for use on or after 9/16/2020 through 8/30/2021.

STU#:00208657 
Version 3.1 
 11/25/2019
D. Walega, MD STU00208657
V 3.1 11/25/2019
Page 17 of 21
Data required for the primary outcome variable, i.e., mean daily frequency of severe hot 
flashes in the study sample at 6 months after the intervention vs. the baseline daily 
frequency of hot flashes in the study sample, will be reported as the mean ± SD if 
appropriate, or as the median (IQR) otherwise. The primary outcome data will be 
evaluated using a paired t-test if the data are approximately normally distributed, or using 
with the Wilcoxon matched pairs signed rank test if they are not. The mean difference 
and 95% CI will be calculated. The criterion for rejection of the null hypothesis (i.e. no 
change over the baseline to 6-month follow-up assessment of the mean weekly 
frequency of severe hot flashes) will be a two-tailed p < 0.05.
For AE analysis, safety and tolerability will be summarized descriptively by providing the 
frequency of adverse events by severity, type, and attribution.  
Differences from baseline and associated 95% CIs will be calculated for planned 
analyses. Variables that are approximately normally distributed (e.g., hot flash frequency) 
will be summarized as mean ± SD. These data at baseline, 1, 3, and 6 months will be 
compared using the one-way repeated measures analysis of variance with pairwise 
multiple comparison with baseline made using the Holm-Sidak method when appropriate.
 
The criterion for rejection of the null hypothesis for all of the secondary analyses will be a 
two-tailed P < 0.05, as this is an exploratory study. 
With severe HF frequency selected as the primary outcome, > 35% reduction from 
baseline to 6 months will be considered to be clinically significant. However, as this is an 
exploratory study, a larger reduction was used for the power analysis presented above.
If this study shows meaningful treatment effects in this study population, we plan to 
further evaluate our hypotheses in a larger, randomized blinded sham controlled study.  
We anticipate that results of the current proposed study will provide more accurate 
estimates of HF frequency and variability than currently available in the literature, and 
these data can be used to design a rigorous larger RCT. 
Given the small sample size, we do not plan on a midterm analysis or futility assessment. 
All data will be de-identified and recorded in duplicate on electronic study-specific case 
report forms (CRFs) REDcap. Participants will be given a study identification number that 
will be reported on all CRFs and source documents. Only the PI and authorized staff, 
according to the list of Authorized Study Personnel, are entitled to make entries on the 
CRF. Personal patient data will be kept confidential. Patient documentation will identify a 
patient by initials and study number only. The PI will keep in his file a Patient 
Identification and Enrollment List. To allow compliance with GCP principles, each patient 
will be asked for consent regarding the access to source documents for monitoring, 
audits, and inspections. Data both electronic and paper will be destroyed 5 years after 
manuscript completion using current vendors and department protocol.
18.0
PROVISIONS TO PROTECT THE PRIVACY INTERESTS OF PARTICIPANTS
Data will be de-identified and given a study identification number. The PI will keep in his 
file a subject identifier log. To allow compliance with GCP principles, each patient will be 
IRB #: STU00208657 Approved by NU IRB for use on or after 9/16/2020 through 8/30/2021.

STU#:00208657 
Version 3.1 
 11/25/2019
D. Walega, MD STU00208657
V 3.1 11/25/2019
Page 18 of 21
asked for consent regarding the access to source documents for monitoring, audits, and 
inspections. During the consent process they will be reassured that their data will be de-
identified and personal patient data will be kept confidential
19.0
COMPENSATION FOR RESEARCH-RELATED INJURY
N/A
20.0
ECONOMIC BURDEN TO PARTICIPANTS
N/A
21.0
CONSENT PROCESS
Participants will be consented in the NMH Pain Clinic (259 East Erie Street, Suite 1400) 
or other similar location by authorized research staff. Authorized research staff will 
explain the consent document. Each section of the form will be discussed, taking time to 
highlight the purpose of the study, procedures, risks, confidentiality measures taken to 
protect the participant, and how to revoke/withdraw consent, if desired, and to answer 
any questions the participant may have. They will also be informed that participation in 
this study is completely optional and regardless of their participation their care will not be 
negatively impacted. Subjects will be given ample time as they need to make their 
decision. The participants will receive a signed copy of the consent.
22.0
PROTECTED HEALTH INFORMATION/HIPPA
HIPPA Authorization will be obtained from all research subjects through the consent 
document. Subjects will give us the permission to use personal health information that 
includes health information in the medical records and information that can identify them. 
Personal health information may include the subjects name, address, or phone number. 
Health information we collect and use for this research includes 
•All information in a medical record 
•Results of physical examinations
•Medical history
•Lab tests, or certain health information indicating or relating to a particular condition as 
well diaries and questionnaires
•Records about study medication or drugs
•Records about study devices
23.0
QUALIFICATIONS TO CONDUCT RESEARCH AND RESOURCES AVAILABLE
There are > 1000 patients with prostate cancer treated annually at NMH, ensuring the 
patient sample projections can be achieved. The principal investigator has over 20+ years 
of clinical experience performing the SGB intervention, and has ongoing NIH sponsored 
research studying the effects of SGB in postmenopausal women. He has authored 
several peer reviewed articles on the topic of SGB for pain indications and for hot flashes. 
Authorized research personnel have years of clinical research experience. All research 
team members have completed the necessary regulatory training.  We anticipate 1-2 
potential cases per week. Authorized research personnel will have dedicated time to 
recruit patients. All authorized research personnel are informed about the protocol and 
their duties and functions.
24.0
WAIVER OR ALTERATION OF CONSENT PROCESS 
NA
IRB #: STU00208657 Approved by NU IRB for use on or after 9/16/2020 through 8/30/2021.

STU#:00208657 
Version 3.1 
 11/25/2019
D. Walega, MD STU00208657
V 3.1 11/25/2019
Page 19 of 21
25.0
NON-ENGLISH SPEAKING PARTICIPANTS 
NA 
26.0
STUDY-WIDE RECRUITMENT METHODS
Local methods previously described. 
 
27.0    REFERENCES
1.
Gonzalez BD, Small BJ, Cases MG, Williams NL, Fishman MN, Jacobsen PB, et al. 
Sleep disturbance in men receiving androgen deprivation therapy for prostate cancer: 
The role of hot flashes and nocturia. Cancer. 2018;124(3):499-506.
2.
Charig CR, Rundle JS. Flushing. Long-term side effect of orchiectomy in treatment of 
prostatic carcinoma. Urology. 1989;33(3):175-8.
3.
Dosani 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;29(10):696-701.
4.
Grunfeld 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;22(4):425-33.
5.
Kouriefs C, Georgiou M, Ravi R. Hot flushes and prostate cancer: pathogenesis and 
treatment. BJU Int. 2002;89(4):379-83.
6.
Nishiyama 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;11(9):735-41.
7.
Frisk J. Managing hot flushes in men after prostate cancer--a systematic review. 
Maturitas. 2010;65(1):15-22.
8.
Sharifi N, Gulley JL, Dahut WL. Androgen deprivation therapy for prostate cancer. 
JAMA. 2005;294(2):238-44.
9.
Gavin AT, Donnelly D, Donnelly C, Drummond FJ, Morgan E, Gormley GJ, et al. 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;6(12):e012952.
10.
Eziefula 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;22(12):2823-
30.
11.
Gonzalez BD, Jim HS, Donovan KA, Small BJ, Sutton SK, Park J, et al. Course and 
Moderators of Hot Flash Interference during Androgen Deprivation Therapy for Prostate 
Cancer: A Matched Comparison. J Urol. 2015;194(3):690-5.
12.
Zhou ES, Bober SL, Nekhlyudov L, Hu JC, Kantoff PW, Recklitis CJ. Physical and 
emotional health information needs and preferences of long-term prostate cancer 
survivors. Patient Educ Couns. 2016;99(12):2049-54.
13.
Hutton B, Yazdi F, Bordeleau L, Morgan S, Cameron C, Kanji S, et al. Comparison of 
physical interventions, behavioral interventions, natural health products, and 
pharmacologics to manage hot flashes in patients with breast or prostate cancer: 
protocol for a systematic review incorporating network meta-analyses. Syst Rev. 
2015;4:114.
IRB #: STU00208657 Approved by NU IRB for use on or after 9/16/2020 through 8/30/2021.

STU#:00208657 
Version 3.1 
 11/25/2019
D. Walega, MD STU00208657
V 3.1 11/25/2019
Page 20 of 21
14.
Nguyen PL, Jarolim P, Basaria S, Zuflacht JP, Milian J, Kadivar S, et al. Androgen 
deprivation therapy reversibly increases endothelium-dependent vasodilation in men 
with prostate cancer. J Am Heart Assoc. 2015;4(4).
15.
Nguyen PL. Radiation therapy for node-positive prostate cancer: it's time for a 
randomized trial. Oncology (Williston Park). 2015;29(2):116-7.
16.
Nguyen PL, Alibhai SM, Basaria S, D'Amico AV, Kantoff PW, Keating NL, et al. Adverse 
effects of androgen deprivation therapy and strategies to mitigate them. Eur Urol. 
2015;67(5):825-36.
17.
Ahmadi H, Daneshmand S. Androgen deprivation therapy: evidence-based management 
of side effects. BJU Int. 2013;111(4):543-8.
18.
Vitolins MZ, Griffin L, Tomlinson WV, Vuky J, Adams PT, Moose D, et al. Randomized 
trial to assess the impact of venlafaxine and soy protein on hot flashes and quality of life 
in men with prostate cancer. J Clin Oncol. 2013;31(32):4092-8.
19.
Irani J, Salomon L, Oba R, Bouchard P, Mottet N. Efficacy of venlafaxine, 
medroxyprogesterone acetate, and cyproterone acetate for the treatment of vasomotor 
hot flushes in men taking gonadotropin-releasing hormone analogues for prostate 
cancer: a double-blind, randomised trial. Lancet Oncol. 2010;11(2):147-54.
20.
Walega DR, Rubin LH, Banuvar S, Shulman LP, Maki PM. Effects of stellate ganglion 
block on vasomotor symptoms: findings from a randomized controlled clinical trial in 
postmenopausal women. Menopause. 2014;21(8):807-14.
21.
Othman AH, Zaky AH. Management of hot flushes in breast cancer survivors: 
comparison between stellate ganglion block and pregabalin. Pain Med. 2014;15(3):410-
7.
22.
Lipov EG, Joshi JR, Sanders S, Wilcox K, Lipov S, Xie H, et al. Effects of stellate-
ganglion block on hot flushes and night awakenings in survivors of breast cancer: a pilot 
study. Lancet Oncol. 2008;9(6):523-32.
23.
Pachman DR, Barton D, Carns PE, Novotny PJ, Wolf S, Linquist B, et al. Pilot evaluation 
of a stellate ganglion block for the treatment of hot flashes. Support Care Cancer. 
2011;19(7):941-7.
24.
Haest K, Kumar A, Van Calster B, Leunen K, Smeets A, Amant F, et al. Stellate ganglion 
block for the management of hot flashes and sleep disturbances in breast cancer 
survivors: an uncontrolled experimental study with 24 weeks of follow-up. Ann Oncol. 
2012;23(6):1449-54.
25.
Felix B, Catalin D, Miolan JP, Niel JP. Effects of testosterone on the electrical properties 
and nicotinic transmission of the major pelvic and coeliac ganglion neurones. J 
Neuroendocrinol. 2001;13(2):193-8.
26.
Westerhaus MJ, Loewy AD. Central representation of the sympathetic nervous system in 
the cerebral cortex. Brain Res. 2001;903(1-2):117-27.
27.
Han Y, Fu L, Sun W, Cao J, Xie R, Zhou P, et al. Neuroprotective effects of testosterone 
upon cardiac sympathetic function in rats with induced heart failure. Eur J Pharmacol. 
2009;619(1-3):68-74.
28.
Lara H, Galleguillos X, Arrau J, Belmar J. Effect of castration and testosterone on 
norepinephrine storage and on the release of [(3)H]norepinephrine from rat vas 
deferens. Neurochem Int. 1985;7(4):667-74.
29.
Khalid M, Ilhami N, Giudicelli Y, Dausse JP. Testosterone dependence of salt-induced 
hypertension in Sabra rats and role of renal alpha(2)-adrenoceptor subtypes. J 
Pharmacol Exp Ther. 2002;300(1):43-9.
IRB #: STU00208657 Approved by NU IRB for use on or after 9/16/2020 through 8/30/2021.

STU#:00208657 
Version 3.1 
 11/25/2019
D. Walega, MD STU00208657
V 3.1 11/25/2019
Page 21 of 21
30.
Lipov E, Kelzenberg B, Rothfeld C, Abdi S. Modulation of NGF by cortisol and the 
Stellate Ganglion Block - is this the missing link between memory consolidation and 
PTSD? Med Hypotheses. 2012;79(6):750-3.
31.
Lipov EG, Slavin KV. More evidence supporting unified theory of stellate ganglion block. 
Med Hypotheses. 2013;81(1):146.
32.
Meusburger SM, Keast JR. Testosterone and nerve growth factor have distinct but 
interacting effects on structure and neurotransmitter expression of adult pelvic ganglion 
cells in vitro. Neuroscience. 2001;108(2):331-40.
33.
Tirassa P, Thiblin I, Agren G, Vigneti E, Aloe L, Stenfors C. High-dose anabolic 
androgenic steroids modulate concentrations of nerve growth factor and expression of 
its low affinity receptor (p75-NGFr) in male rat brain. J Neurosci Res. 1997;47(2):198-
207.
34.
Carpenter JS. The Hot Flash Related Daily Interference Scale: a tool for assessing the 
impact of hot flashes on quality of life following breast cancer. J Pain Symptom Manage. 
2001;22(6):979-89.
35.
Irani J, Salomon L, Oba R, Bouchard P, Mottet N. Efficacy of venlafaxine, 
medroxyprogesterone acetate, and cyproterone acetate for the treatment of vasomotor 
hot flushes in men taking gonadotropin-releasing hormone analogues for prostate 
cancer: a double-blind, randomised trial. Lancet Oncol. 2010 Feb;11(2):147-54. 
IRB #: STU00208657 Approved by NU IRB for use on or after 9/16/2020 through 8/30/2021.