Clinical trial NCT03796195
Conditions: Prostate Cancer Hot Flashes
Keywords: Stelate Ganglion Block
Sponsor: Northwestern University
Start date: 2019-11-13; Completion date: 2021-07-16
Enrollment: 1 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief 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). 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.

Detailed description:

Arms: arm 1: Guided right sided stelate ganglion block using .5% bupivacaine (5mLs)
Interventions: intervention 1: .5% Bupivacaine
Intervention descriptions: intervention 1: Ultrasound guided right sided stelate ganglion block using .5% bupivacaine (5mLs)

Protocol documents:
Prot_SAP_000.pdf: 
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
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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 
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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.  
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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.  
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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 
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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.
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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
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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.
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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 
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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
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*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 
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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.
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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
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
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
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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
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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”. 
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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.
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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 
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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
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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.
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Grunfeld EA, Hunter MS, Yousaf O. Men's experience of a guided self-help intervention 
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5.
Kouriefs C, Georgiou M, Ravi R. Hot flushes and prostate cancer: pathogenesis and 
treatment. BJU Int. 2002;89(4):379-83.
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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.
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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 
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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.
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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.
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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-
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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.
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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.
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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.

ICF_001.pdf: 
NCT03796195
Title of the Study: Does Stellate Ganglion Blockade (SGB) in Men Treated for
Prostate Cancer Improve Hot Flashes? A Pilot Prospective Cohort Study
Informed Consent Form Version 1.2  09/07/2020


Permission to Take Part in a Human Research Study
Do not sign this consent if today’s date is later than the stated expiration date above.
Version:  V 1.2 09/07/2020
Page 1 of 11
Title of Research Study: Does Stellate Ganglion Blockade (SGB) in Men Treated for 
Prostate Cancer Improve Hot Flashes?  A Pilot Prospective Cohort Study 
Investigator: David R. Walega, MD, MSCI
Supported By: This research is supported by the Department of Anesthesiology, Feinberg 
School of Medicine, Northwestern University
Financial Interest Disclosure: The following disclosure is made to give you an opportunity 
to decide if this relationship will affect your willingness to participate in this research study:
If your doctor is also the person responsible for this research study, please note that he is 
interested in both your clinical care and the conduct of this research study. You have the right to 
discuss this study with another person who is not part of the research team before deciding 
whether to participate in the research.
Why am I being asked to take part in this research study?
We are asking you to take part in this research study because you are a patient with prostate 
cancer who experiencing bothersome hot flashes. 
What should I know about a research study?

Someone will explain this research study to you.

Whether or not you take part is up to you.

You can choose not to take part.

You can agree to take part and later change your mind.

Your decision will not be held against you.

You can ask all the questions you want before you decide.
Why is this research being done?
This study is being done to determine whether stellate ganglion block (SGB) with local 
anesthetic can reduce the number and severity of hot flashes in men with prostate cancer on 
ADT who have hot flashes. The stellate ganglion is a nerve located in the deep tissues on the 
front of the neck.
Hot flashes can have a significant impact on daily living, disrupt sleep, and lead to fatigue and 
irritability during the day. Hot flashes are the most common reason that women seek hormonal 
therapy. However, for some women this is not an option. 
Key Information: 
The first few pages of this document include a summary of this study to help you 
decide whether or not to participate. Detailed information is provided after the 
summary.
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We recently completed a study of SGB in women with natural or surgical menopause, in which 
we found a 52% decrease in moderate to very severe hot flashes in women who underwent a 
single SGB with bupivacaine, a local anesthetic, as compared to a 4% decrease in women in 
the control group who underwent an injection of saline.  In this study, we would like to see if this 
same treatment that helps women could be helpful in men with prostate cancer who have hot 
flashes related to their cancer treatment.
The stellate ganglion injection (study procedure) has been in clinical use for more than 50 years 
in treating certain disease states and chronic pain.  In the past, the study procedure has not 
been used to relieve hot flashes and the use of the study procedure with local anesthetic for the 
reduction of hot flashes is considered experimental. 
How long will the research last and what will I need to do?
We expect that you will be in this research study for approximately seven months. 
We are studying the hot flashes that you report on a daily paper diary.
To study how hot flashes relate to other aspects of your life, like your quality of life, sleep, mood, 
you will be asked to complete questionnaires before the injection and weekly following the study 
procedure.
More detailed information about the study procedures can be found under the section What 
happens if I say “Yes, I want to be in this research”?
Is there any way being in this study could be bad for me?
There are risks associated with participation in this study.
Stellate ganglion injection carries the potential very rare risk of infection at the injection site,
bleeding or blood clot formation at the injection site, seizures (sudden, uncontrolled muscle
spasms and loss of consciousness) related to the local anesthetic used for the injection 
procedure, and nerve injury which may present as temporary paresthesia (numbness) or 
weakness of the right arm or hand. All of these rare risks that are minimized with the use of 
fluoroscopic guidance (direct visualization with low dose x-ray).
Temporary voice hoarseness, temporary mild shortness of breath, temporary difficulty
swallowing, and temporary changes in your blood pressure may occur after the stellate ganglion
injection from the 0.5% bupivacaine numbing medicine. Possible reactions from the 0.5%
bupivacaine used in this study last 6-8 hours. Minor soreness at the injection site could last 1-2
days.
There is a risk of allergic reaction to the dye used in the fluoroscopic guidance or the 1%
lidocaine used to numb the skin before placement of the needle for the procedure.
The cumulative radiation exposure from the use of fluoroscopic guidance for the injection is 
considered small and is not likely to adversely affect you.
The questionnaires used in this study may make you feel emotionally uncomfortable. 
There is a risk of loss of confidentiality. 
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In addition to these risks, this research may hurt you in ways that are unknown. 
More detailed information about the risks of this study can be found under “Is there any way 
being in this study could be bad for me? (Detailed Risks)”
Will being in this study help me anyway?
We cannot promise any benefits to you or others from your taking part in this research.
However, possible benefits include a reduction in the severity or frequency of hot flashes, an
improvement in your overall feeling of well-being and quality of life. Of course, because 
individuals respond differently, no one can know in advance if it will be helpful in your particular 
case. Taking part in this study may help scientists to better understand treatments for hot 
flashes in men with prostate cancer. 
What happens if I do not want to be in this research?
Participation in research is completely voluntary. You decide whether or not to participate. If you 
choose to not participate, there will be no penalty to you or loss of benefit to which you are 
entitled.  
Instead of being in this research study, there are alternative treatment options such as anti-
depressants (selective serotonin reuptake inhibitors (SSRIs)) or membrane stabilizer/anti-
seizure drugs (like Neurontin (gabapentin), Lyrica (pregabalin) to manage your hot flashes.
Who can I talk to?
If you have questions, concerns, or complaints, or think the research has hurt you, talk to Dr. 
Walega or a member of the research team at 312-695-2500.They are available to speak to you  
M-F 8:00 am to 5:00 pm. If you have an urgent or serious issue that cannot wait, you may page 
Dr. Walega at 312-707-0328 if you need to speak to him. 
This research has been reviewed and approved by an Institutional Review Board (IRB). You 
may contact them at (312) 503-9338 or irb@northwestern.edu if:

Your questions, concerns, or complaints are not being answered by the research team.

You cannot reach the research team.

You want to talk to someone besides the research team.

You have questions about your rights as a research participant.

You want to get information or provide input about this research.
How many people will be studied?
We expect 18 people to be in this research study. 
What happens if I say “Yes, I want to be in this research”?
Screening:  Visit 1
You will be asked to come to the Pain Medicine Center at 259 E. Erie Street, Suite 14-101 to 
sign and review the consent form.  After we have reviewed the consent form with you and have 
answered your questions and you have signed the consent form, you will be interviewed to 
determine if you are a candidate for the study. We will ask you to provide information about 
yourself and your medical history. 
Recording of Hot Flashes
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Before having the SGB procedure you will be asked to maintain a daily paper diary of your hot 
flashes, recording the number and severity using a scale that will be provided to you. You will be 
asked to do this for one week prior to the SGB procedure. You will also record any comments 
about the hot flashes you experience each day. 
This visit will take approximately 1/2 hour.
You will be scheduled to receive the study procedure with Dr. David Walega in the Department 
of Anesthesiology at a separate visit.
Questionnaires
You will complete questionnaires about your everyday functioning, mood and sleep. You may 
refuse to answer any question that you don’t wish to answer. If you become uncomfortable at 
any time and wish to stop, we will stop the tests. These forms are:
Hot Flash Related Daily Interference Scale (HFRDIS) 
PROMIS SF4a (sleep)
The forms should take approximately 15-20 minutes to complete.
Visit 2 
Stellate Ganglion Injection Procedure
You will be asked to go the Pain Medicine Center at 259 E. Erie Street, 14th floor for the SGB 
procedure. You will be interviewed to assess your health status and a brief physical exam will 
be performed by Dr. Walega. If you are determined to be a candidate for the procedure by Dr. 
Walega, you will receive the study procedure (stellate ganglion injection with 0.5% bupivacaine, 
a local anesthetic or numbing medication). There is no placebo or sham “fake” procedure as 
part of this study.
Before the injection procedure, a medication line will be inserted into a vein in your arm or hand. 
An oxygen monitor and blood pressure cuff will also be placed. You will be positioned on your 
back for this procedure. Your neck will be swabbed with disinfectant to clean the skin, and 
sterile equipment and technique will be used for the entire procedure. Your blood pressure will 
be checked every 5 minutes, and your pulse and oxygen level will be monitored continuously 
during the procedure. You will be asked to remain still for the procedure.
Low dose x-ray (fluoroscopy machine) will be used to help guide the injection at the region of 
the 6th bone in your neck (C6) on the right side of the neck. The injection site will be identified 
and 1% lidocaine (local anesthesia numbing medicine) will be injected to the skin overlying the 
target bone landmark to numb the injection site.  
A small needle will be placed through the numbed skin on the front of the right side of the neck 
to make contact with the tissues over the C6 (neck) bone. The correct position of this needle will 
be confirmed by injecting a small amount of dye that can be seen by Dr. Walega under x-ray. 
Then 5 cc or about 1 teaspoon of 0.5% bupivacaine (local anesthesia numbing medicine) will be 
injected and the needle will be removed. A band aid will be placed at the needle placement site. 
You can remove the band aid later that day. 
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During the injection procedure, you will feel a sting or burn sensation on the skin where the 
numbing medicine is injected which lasts 5-10 seconds. You will feel the pressure of Dr. 
Walega’s fingers on the right side of your neck while the needle is positioned for the stellate 
ganglion and this lasts about 60 seconds. You may feel a pressure or fullness sensation on the 
neck or throat when the medicine is injected and this sensation goes away after the needle is 
removed. 
This procedure will take a few minutes. After the injection procedure is completed, you will be 
moved to the recovery room in the clinic and you will rest on a bed for about half an hour for 
observation. Your vital signs will be checked every 5 minutes. You will be offered juice or water 
after you have recovered. Prior to discharging you, Dr. Walega will evaluate you for side effects 
of the procedure.  
You will be given written discharge instructions when you are ready to leave the clinic. You will 
be instructed to contact the study coordinator or Dr. Walega if you experience the following 
symptoms: swelling on the front of the right neck, abrupt weakness or progressive weakness in 
your legs, persistent numbness or pain at or near the injection site, rash, welts, or hives 
anywhere on your body, difficulty swallowing or pain with swallowing, chills or fever (101º F or 
greater), drainage or signs of infection at the injection site on your neck.
You can rest for the remainder of the day, or return to your normal activities like work. If you 
received sedation, you cannot drive a car, operate machinery, or make important legal decisions 
for the rest of the day. You will also be asked to have someone accompany you to your 
appointment. Even if you think you do not want sedation for your procedure, it is a good idea to 
bring someone with you in case you change your mind and decide to have sedation.  You will 
have no other restrictions. 
You will continue to complete your hot flash diary for the duration of the study. You will be asked 
to complete a weekly Hot Flash Related Daily Interference Scale (HFRDIS) questionnaire. The 
questionnaire takes 5 minutes to complete. At 1, 3, and 6 months after study procedure you will 
be asked to complete the following questionnaires in addition to providing your hot flash diaries. 
The questionnaires can be completed via email generated from REDcap (data collection site). 
PROMIS SF4a (sleep)
Patient Global Impression of Change Score (PGIC)
The questionnaires take 15-20 minutes to complete.  You can mail these or you may receive an 
email link that will allow you to complete these questionnaires electronically via email generated 
by REDCap (data collection server).  
Your part in this study will last for approximately seven months and will involve 2 visits. 
Will I be told about new information that may affect my decision to participate? 
During the course of the study, you will be informed of any significant new findings (either good 
or bad), such as changes in the risks or benefits resulting from participation in the research or 
new alternatives to participation, that might cause you to change your mind about continuing in 
the study.  If new information is provided to you, your consent to continue participating in this 
study will be re-obtained.
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What are my responsibilities if I take part in this research?
If you take part in this research, you will be responsible to: complete your written hot flash diary 
for the duration of the study, follow the study doctor's pre-procedure instruction which will be 
given to you in writing.
What happens if I say “Yes”, but I change my mind later?
You can leave the research study at any time; it will not be held against you. 
If you decide to leave the research, contact the research team so that we don't continue to call 
you or contact you for study visits and so we can pay you for your participation. 
Choosing not to be in this study or to stop being in this study will not result in any penalty to you 
or loss of benefit to which you are entitled.  Specifically, your choice not to be in this study will 
not negatively affect your right to any present or future medical treatment or your present or 
future employment 
If you stop being in the research, already collected data may not be removed from the study 
database. You will be asked whether the investigator can collect data from your routine medical 
care.  If you agree, this data will be handled the same as research data. 
Detailed Risks: Is there any way being in this study could be bad for me?
This research may hurt you in the following ways: 
Stellate Ganglion Block with 0.5% bupivacaine local anesthetic (numbing medicine) 
Stellate ganglion injection carries the potential very rare risk of infection at the injection site, 
bleeding or blood clot formation at the injection site, seizures (reversible, sudden, uncontrolled 
muscle spasms and loss of consciousness) and nerve injury which may present as temporary 
paresthesia (numbness) and/or weakness of the right arm.  
All of these rare risks are minimized with the use of fluoroscopic guidance (visualization with a 
type of x-ray). Other complications related to the stellate ganglion injection that can occur are an 
allergic reaction to the dye used in the fluoroscopic guidance, the 1% lidocaine used to numb 
the skin before placement of the needle for the stellate ganglion procedure or the 0.5% 
bupivacaine used in the stellate ganglion injection. Temporary voice hoarseness, temporary 
mild shortness of breath, temporary difficulty swallowing, and temporary changes in your blood 
pressure may occur after the stellate ganglion injection from the 0.5% bupivacaine numbing 
medicine.  Possible reactions from the 0.5% bupivacaine used in this study last 6-8 hours.   
Minor soreness at the injection site could last 1-2 days.
Risk of radiation from the x-ray
X –ray (fluoroscopy) will be used during this research study to guide placement of the needle 
during your injection procedure. The cumulative radiation exposure from these tests is 
considered small and is not likely to adversely affect you or your disease. Radiation risk is equal 
to what you would normally receive in a 24 hour daily exposure.
However, the effects of radiation add up over a lifetime. It is possible that having several of 
these X-rays may add to your risk of injury or disease. When deciding to enter this study, think 
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about your past and future contact with radiation. Examples of contact with radiation include x-
rays or CT scans taken for any reason or radiation therapy for cancer treatment. 
Questionnaires
Answering the questionnaires may make you feel emotionally uncomfortable. You might feel 
anxious, or experience emotional reactions to some of the questions we will be asking you. If 
the question bothers you you can move onto the next question. 
Confidentiality Risks
This study involves the use of your identifiable, personal information and there is a chance that 
a loss of confidentiality could occur. The researchers have procedures in place to lessen the 
possibility of this happening. Certain measures are taken to protect all personal information and 
data, including keeping all data sheets under lock and key and entering data into a non-network 
database that requires a login ID and password made available only to immediate study 
personnel. 
See the section titled: “What happens to the information collected for the research?”.
Unknown Risks
In addition to these risks, this research may hurt you in ways that are unknown. 
If you have experienced any of the above side effects or experienced an adverse event please 
contact the PI: David Walega at the Pain Center. 
What do I need to know about reproductive health and/or sexual activity if I am in 
this study?  
The injection procedure does not have an effect on your reproductive health. There is no 
restriction to sexual activity for the injection procedure. 
Will it cost me anything to participate in this research study?
Taking part in this research study will not lead to any costs to you. 
If you park in the hospital parking lot located on St. Clair Street, between Superior and Huron 
Streets, your parking ticket will be validated by the research staff and paid for up to six hours. 
This validation is only valid for this garage (also known as the Huron/St. Clair garage) and your 
ticket must be validated the day of your study visit. If you park in the Huron/St. Clair garage and 
do not get your parking ticket validated as described, the parking expenses will range from 
$12.50 for 20 minutes or less, up to $52.00 for 24 hours. You may enter the garage from either 
on Huron or Superior streets. Other parking garages in the area around the McGaw Medical 
Center may cost more, or less than this garage, but your parking ticket at these other locations 
will not be validated.
Will being in this study help me in any way?
We cannot promise any benefits to you or others from your taking part in this research. 
However, possible benefits include a reduction in the severity or frequency of hot flashes, an 
improvement in your overall feeling of well-being and ability to perform the functions of daily 
living impacted by hot flashes.  Of course, because individuals respond differently, no one can 
know in advance if it will be helpful in your particular case. 
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Taking part in this study may help scientists to better understand treatments for hot flashes in 
men with prostate cancer receiving treatment.  
What happens to the information collected for the research?
Efforts will be made to limit the use and disclosure of your personal information, including 
research study and medical records, to people who have a need to review this information. We 
cannot promise complete secrecy. Organizations that may inspect and copy your information 
include the IRB and other representatives of this institution. 
Study monitors, auditors, from the Institutional Review Board (IRB), the Northwestern University 
Office for Research Integrity, the US Office of Research Integrity (ORI), and the US Office for 
the Protection of Human Research Protections (OHRP), the US Food and Drug Administration 
(FDA) may be granted direct access to your medical records to conduct and oversee the 
research. By signing this document, you are authorizing this access. We may publish the results 
of this research. However, we will keep your name and other identifying information confidential.
A description of this clinical trial will be available at http://www.ClinicalTrials.gov, as required by 
U.S. Law. This Web site will not include information that can identify you. At most, the Web site 
will include a summary of the results. You can search this Web site at any time.
Data Sharing 
De-identified data from this study may be shared with the research community at large to 
advance science and health. We will remove or code any personal information that could 
identify you before files are shared with other researchers to ensure that, by current scientific 
standards and known methods, no one will be able to identify you from the information we 
share. Despite these measures, we cannot guarantee anonymity of your personal data.
Can I be removed from the research without my OK?
The person in charge of the research study can remove you from the research study without 
your approval. Possible reasons for removal include the following: if it appears to be medically 
harmful to you, if you fail to follow directions for participating in the study, if it is later discovered 
that you do not meet the study eligibility requirements, at the discretion of the study doctor or, if  
the study is canceled.
We will tell you about any new information that may affect your health, welfare, or choice to stay 
in the research.
What else do I need to know?
If you become ill or get injured as a result of this study (medications, devices or procedures), 
you should seek medical treatment through your doctor or treatment center of choice. You 
should promptly tell the study doctor about any illness or injury.  
The hospital [university, researchers] will not pay for medical care required because of a bad 
outcome resulting from your participation in this research study. This does not keep you from 
seeking to be paid back for care required because of a bad outcome.
If you agree to take part in this research study, we will pay you $100.00 by check at study 
completion for your time and effort. The check will be mailed to your home.  
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The Accounting Services at Northwestern University will be given your name, address, and 
Social Security Number in order to issue a check for your study participation. Study payments 
are considered taxable income and reportable to the IRS. A Form 1099 will be sent to you if 
your total payments are $600 or more in a calendar year.
HIPAA Authorization
We are committed to respect your privacy and to keep your personal information confidential.  
When choosing to take part in this study, you are giving us the permission to use your personal 
health information that includes health information in your medical records and information that 
can identify you. For example, personal health information may include your name, address, 
phone number or social security number. Your health information we may collect and use for 
this research includes: 

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

Billing information

Substance Use Disorder information: current substance abuse is an exclusion to 
participate in this study.

Mental Health information: from the questionnaires 
All Information in a medical record 
You have the right to inspect and copy the mental health and developmental disabilities records 
that will be collected as part of this study.
This consent expires on 09/30/2030. After this date, Northwestern University may not gather 
new information about you, use or disclose your personal health information collected in this 
study for any purpose other than the research study described in this consent unless 
Northwestern University obtains permission to do so from you.  Illinois State Law permits use 
and disclosure of your mental health information only to the extent specified in this document.
During this study, you may be coming to a Northwestern Memorial Healthcare Corporation entity 
(for example, Northwestern Memorial Hospital, Prentice Women’s Hospital) for research 
appointments or to get clinical services, such as lab tests, needed for the study.  When that 
happens, you will be scheduled for these services through the NMHC computer system.  When 
a clinical exam or lab is done by NMHC or one of its employees for the purpose of this research 
study, that information will be kept in both NMHC’s clinical records and in the study records.
The following clinical providers may give the researchers information about you:  all current and 
previous health care providers, including but not limited to the Shirley Ryan AbilityLab 
(SRALAB), Northwestern Medical Group (NMG), Northwestern Memorial Hospital (NMH), and 
Northwestern Lake Forest Hospital (NLFH).
Once we have the health information listed above, we may share some of this information with 
the following offices or entities outside of Northwestern University and its clinical partners (or 
affiliates):  the Northwestern University Institutional Review Board Office and Office for 
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Research Integrity; the US Office of Research Integrity; the US Office for Human Research 
Protections; the US Food and Drug Administration.  
Any research information shared with outside entities will not contain your name, address, 
telephone or social security number or any other personal identifier unless disclosure of the 
identifier is necessary for review by such parties or is required by law or University policy 
[except that such information may be viewed by the Study sponsor and its partners or 
contractors at the Principal Investigator’s office].
The following entities may receive your health information: 

Authorized members of the Northwestern University and the Shirley Ryan AbilityLab 
workforce, who may need to see your information, such as administrative staff 
members from the Office for Research, Office for Research Integrity and members of 
the Institutional Review Board.

Clinical affiliates, including but not limited to the Shirley Ryan AbilityLab (SRALAB), 
Northwestern Medical Group (NMG), Northwestern Memorial Hospital (NMH), 
Northwestern Lake Forest Hospital (NLFH), and the Ann & Robert H. Lurie Children’s 
Hospital of Chicago (Lurie Children’s).  Your participation in this clinical trial may be 
tracked in an electronic database and may be seen by investigators running other 
trials that you are enrolled in and by your healthcare providers. 

Clinical affiliates, including but not limited to Northwestern Medical Group (NMG), 
Northwestern Memorial Hospital (NMH), and Northwestern Lake Forest Hospital 
(NLFH), for purposes including, but not limited to, the affiliate’s provision of care to 
you and/or the affiliate’s scheduling of appointments and/or billing activities.

Study monitors and auditors who make sure that the study is being done properly, 

Government agencies and public health authorities, such as the Food and Drug 
Administration (FDA) and the Department of Health and Human Services (DHHS).
Those persons who get your health information may not be required by Federal privacy laws 
(such as the Privacy Rule) to protect it. Some of those persons may be able to share your 
information with others without your separate permission.
Also, Federal law/42 CFR Part 2 prohibits unauthorized disclosure of these records. 
The results of this study may also be used for teaching, publications, or for presentation at 
scientific meetings.  
Unless you revoke your consent, it will expire 09/30/2030.
The results of this study may also be used for teaching, publications, or for presentation at 
scientific meetings.  
Although you may revoke consent to participation in this research at any time and in any format, 
you must revoke authorization for use or disclosure of your health information in writing. To 
revoke your authorization, write to:
PI’s Name: David R. Walega, MD, MSCI
Institution: Northwestern University, Feinberg School of Medicine
Department: Department of Anesthesiology
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Address: 251 E. Huron Street, F5-70, Chicago, Illinois, 60611
You do not have to authorize the use or disclosure of your health information; however, you will 
not be allowed to take part in this research study. If you do not authorize the use or disclosure of 
your health information, it will not affect your treatment by health care providers, or the payment 
or enrollment in any health plans, or affect your eligibility for benefits.
A copy of this signed consent document, information about this study, and the results of any test 
or procedure done may be included in your medical records and may be seen by your insurance 
company.
Your signature documents your permission to take part in this research.  
You will be provided a copy of this signed document.
_______________________________________________      __________________
Signature of Participant                                                               Date
_______________________________________________
Printed Name of Participant
_______________________________________________            __________________
Signature of Person Obtaining Consent                                     Date
_______________________________________________
Printed Name of Person Obtaining Consent
My signature below documents that the information in the consent document and any other 
written and information was accurately explained to, and apparently understood by, the 
participant, and that consent was freely given by the participant.  
__________________________________________      
__________________
Signature of Witness to Consent Process                  
Date
___________________________________________   
Printed Name of Person Witnessing Consent Process
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