Clinical trial: NCT03796195
Section: Alternatives
Subsections: Will Being In This Study Help Me Anyway?|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 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.

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.  
Taking part in this study may help scientists to better understand treatments for hot flashes in men with prostate cancer receiving treatment.
Clinical trial: NCT03796195
Section: Confidentiality
Subsections: What Happens To The Information Collected For The Research?|Data Sharing|Hipaa Authorization

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.

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.

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  
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  
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.  
  
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   |
|-----------------------------------------------------|
Clinical trial: NCT03796195
Section: Duration of Study Involvement
Subsections: 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"?
Clinical trial: NCT03796195
Section: Participant Responsibilities
Subsections: 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.
Clinical trial: NCT03796195
Section: Participant's Rights
Subsections: 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.
Clinical trial: NCT03796195
Section: Possible Risks, Discomforts, and Inconveniences
Subsections: Is There Any Way Being In This Study Could Be Bad For Me? There Are Risks Associated With Participation In This Study.|Detailed Risks: Is There Any Way Being In This Study Could Be Bad For Me? This Research May Hurt You In The Following Ways:|Confidentiality Risks|Unknown Risks

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.  
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)"

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  
about your past and future contact with radiation. Examples of contact with radiation include xrays or CT scans taken for any reason or radiation therapy for cancer treatment.

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?".

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.
Clinical trial: NCT03796195
Section: Procedures
Subsections: 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  
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.
Clinical trial: NCT03796195
Section: Purpose of Research
Subsections: 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.  
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.
Clinical trial: NCT03796195
Section: Withdrawal from Study
Subsections: What Happens If I Do Not Want To Be In This Research?|What Happens If I Say "Yes", But I Change My Mind Later?|Can I Be Removed From The Research Without My Ok?

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 antidepressants (selective serotonin reuptake inhibitors (SSRIs)) or membrane stabilizer/antiseizure drugs (like Neurontin (gabapentin), Lyrica (pregabalin) to manage your hot flashes.

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.

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.