<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03796195</url>
  </required_header>
  <id_info>
    <org_study_id>STU00208657</org_study_id>
    <nct_id>NCT03796195</nct_id>
  </id_info>
  <brief_title>(SGB) in Men Treated for Prostate Cancer Improve Hot Flashes</brief_title>
  <official_title>Does Stellate Ganglion Blockade (SGB) in Men Treated for Prostate Cancer Improve Hot Flashes? A Pilot Prospective Cohort Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Northwestern University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Northwestern University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Androgen Deprivation Therapy (ADT) is a critical component of advanced prostate cancer&#xD;
      treatment but causes numerous adverse effects including decreased bone mass, decreased muscle&#xD;
      mass, gynecomastia, erectile dysfunction, loss of sexual desire, depression, disordered&#xD;
      sleep, urinary symptoms, and hot flashes (HF). HF are unpleasant paroxysmal episodes of&#xD;
      flushing, sweating with vasodilation of the face, neck, and chest. These episodes can last&#xD;
      for seconds to minutes and are often associated with night sweats, anxiety, and insomnia and&#xD;
      have negative effects on quality of life.&#xD;
&#xD;
      Stellate ganglion blockade (SGB) with local anesthetic may be an effective treatment of HF in&#xD;
      men on ADT, but has not been studied in any published clinical trials.&#xD;
&#xD;
      The stellate ganglion is a neural structure in the anterior cervical spine region and is part&#xD;
      of the sympathetic nervous system. It has been injected safely in the practice of pain&#xD;
      management for more than 50 years in cases of post herpetic neuralgia (shingles), complex&#xD;
      regional pain syndrome (CRPS) and other painful neuropathies as well as some types of cardiac&#xD;
      dysrhythmias.&#xD;
&#xD;
      Given the frequency and severity and interference of HF in men on ADT for prostate cancer, in&#xD;
      addition to the negative effects HF impose on this patient population and a paucity of&#xD;
      effective treatments, finding alternative treatments for HF in this population is needed.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Enrollment issues&#xD;
  </why_stopped>
  <start_date type="Actual">November 13, 2019</start_date>
  <completion_date type="Actual">July 16, 2021</completion_date>
  <primary_completion_date type="Actual">July 16, 2021</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Hot Flash Frequency Change Baseline to 3 Months After Treatment.</measure>
    <time_frame>3 months after SGB procedure</time_frame>
    <description>Change in mean daily hot flashes using a self-report hot flash diary from baseline to 3 months after stellate ganglion block.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Hot Flash Severity Baseline to 3 Months After Stellate Ganglion Block</measure>
    <time_frame>3 months after stellate ganglion block</time_frame>
    <description>The change in hot flash severity (hot flash frequency x hot flash intensity) between baseline and 3 months after SGB. Hot flash severity is determined using the mean frequency= ((Fmo+Fse))7 where FMi, Fmo and Fse are the weekly total number of mild, moderate or severe HF events. The mean severity= (Fmi+2x Fmo + 3 x Fse)/7 where FMI, Fmo and Fse are the weekly total number of mild, moderate or severe/very severe hot flash events in the case of mean severity, frequency of mild vasomotor symptoms is not counted at baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PROMIS SF4a Score 4 Weeks After Stellate Ganglion Block.</measure>
    <time_frame>4 weeks after stellate ganglion block</time_frame>
    <description>PROMIS SF4a (sleep) Patient Reportee Outcomes Measurement Information System. The PROMIS SF4a is a 4 item questionnaire that queries sleep duration, quality and interruption. This instrument accesses self reported perceptions of sleep quality, sleep depth and restoratoin associated with sleep. This includes perceived difficulties and concerns with getting to sleep or staying asleep, as well as perceptions of the adequacy and satisfaction with sleep. The 4 items are scored 1-5 where 1 is good quality and 5 is poor quality for a total score range of 4 (good quality) to 20 (poor quality).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Global Impression of Change Score (PGIC)</measure>
    <time_frame>4 weeks after stellate ganglion block</time_frame>
    <description>The PGIC assesses the participants improvement in hot flashes from the time of the stellate ganglion block to 4 weeks after the procedure. The PGIC queries how much the hot flashes have improved on a scale of 1 (very much improved) to 7 (very much worse).</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">1</enrollment>
  <condition>Prostate Cancer</condition>
  <condition>Hot Flashes</condition>
  <arm_group>
    <arm_group_label>.5% Bupivacaine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Guided right sided stelate ganglion block using .5% bupivacaine (5mLs)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>.5% Bupivacaine</intervention_name>
    <description>Ultrasound guided right sided stelate ganglion block using .5% bupivacaine (5mLs)</description>
    <arm_group_label>.5% Bupivacaine</arm_group_label>
    <other_name>Right sided stelate ganglion block (SGB)</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Men with prostate cancer (with or without metastatic disease) on ADT for at least 2&#xD;
             months&#xD;
&#xD;
          2. Age less than 65 years&#xD;
&#xD;
          3. Body Mass Index (BMI) less than 32&#xD;
&#xD;
          4. Willingness to undergo image guided intervention&#xD;
&#xD;
          5. Greater than 28 hot flashes per week.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Conditions that preclude SGB or sham intervention (e.g., anatomic abnormalities of the&#xD;
             anterior neck or cervical spine; metastatic disease in or near the cervical spine;&#xD;
             goiter;cardiac/pulmonary compromise; sleep apnea; acute illness/infection;&#xD;
             coagulopathy or bleeding disorder; allergic reactions/contraindications to a local&#xD;
             anesthetic or contrast dye)&#xD;
&#xD;
          2. Current treatment of prostate cancer with radium or chemotherapy&#xD;
&#xD;
          3. Use of treatments in the past two months that can affect HF (e.g., testosterone or&#xD;
             androgen supplementation) Note: SSRIs, serotonin norepinephrine uptake inhibitors, and&#xD;
             membrane stabilizers will be allowed but must be on stable unchanged dose for at least&#xD;
             8 weeks)&#xD;
&#xD;
          4. Inability to write, speak, or read in English&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Men with prostate cancer with bothersome hot flashes.</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>David Walega, MD, MS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Northwestern University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Northwestern Memorial Hospital</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60611</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Gonzalez BD, Small BJ, Cases MG, Williams NL, Fishman MN, Jacobsen PB, Jim HSL. Sleep disturbance in men receiving androgen deprivation therapy for prostate cancer: The role of hot flashes and nocturia. Cancer. 2018 Feb 1;124(3):499-506. doi: 10.1002/cncr.31024. Epub 2017 Oct 26.</citation>
    <PMID>29072790</PMID>
  </reference>
  <reference>
    <citation>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 Oct;29(10):696-701. doi: 10.1016/j.clon.2017.06.009. Epub 2017 Jul 13.</citation>
    <PMID>28712786</PMID>
  </reference>
  <reference>
    <citation>Grunfeld EA, Hunter MS, Yousaf O. Men's experience of a guided self-help intervention for hot flushes associated with prostate cancer treatment. Psychol Health Med. 2017 Apr;22(4):425-433. doi: 10.1080/13548506.2016.1195504. Epub 2016 Jun 13.</citation>
    <PMID>27294289</PMID>
  </reference>
  <reference>
    <citation>Kouriefs C, Georgiou M, Ravi R. Hot flushes and prostate cancer: pathogenesis and treatment. BJU Int. 2002 Mar;89(4):379-83. doi: 10.1046/j.1464-4096.2001.01761.x. No abstract available.</citation>
    <PMID>11872028</PMID>
  </reference>
  <reference>
    <citation>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 Sep;11(9):735-41. doi: 10.1111/j.1442-2042.2004.00896.x.</citation>
    <PMID>15379937</PMID>
  </reference>
  <reference>
    <citation>Frisk J. Managing hot flushes in men after prostate cancer--a systematic review. Maturitas. 2010 Jan;65(1):15-22. doi: 10.1016/j.maturitas.2009.10.017. Epub 2009 Dec 4.</citation>
    <PMID>19962840</PMID>
  </reference>
  <reference>
    <citation>Trump DL. Commentary on &quot;association of androgen deprivation therapy with cardiovascular death in patients with prostate cancer: a meta-analysis of randomized trials.&quot; Nguyen PL, Je Y, Schutz FA, Hoffman KE, Hu JC, Parekh A, Beckman JA, Choueiri TK, Department of Radiation Oncology, Dana-Farber Cancer Institute, Brigham and Women's Hospital, 75 Francis Street, Boston, MA 02115, USA: JAMA 2011;306(21):2359-66. Urol Oncol. 2012 Sep;30(5):746-7. doi: 10.1016/j.urolonc.2012.06.007. No abstract available.</citation>
    <PMID>23021559</PMID>
  </reference>
  <reference>
    <citation>Gavin AT, Donnelly D, Donnelly C, Drummond FJ, Morgan E, Gormley GJ, Sharp L. Effect of investigation intensity and treatment differences on prostate cancer survivor's physical symptoms, psychological well-being and health-related quality of life: a two country cross-sectional study. BMJ Open. 2016 Dec 19;6(12):e012952. doi: 10.1136/bmjopen-2016-012952. Erratum In: BMJ Open. 2017 Jan 23;7(1):e012952corr1.</citation>
    <PMID>27993906</PMID>
  </reference>
  <reference>
    <citation>Eziefula CU, Grunfeld EA, Hunter MS. 'You know I've joined your club... I'm the hot flush boy': a qualitative exploration of hot flushes and night sweats in men undergoing androgen deprivation therapy for prostate cancer. Psychooncology. 2013 Dec;22(12):2823-30. doi: 10.1002/pon.3355. Epub 2013 Jul 28.</citation>
    <PMID>23893467</PMID>
  </reference>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>January 3, 2019</study_first_submitted>
  <study_first_submitted_qc>January 4, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 8, 2019</study_first_posted>
  <results_first_submitted>July 13, 2022</results_first_submitted>
  <results_first_submitted_qc>January 3, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">January 25, 2023</results_first_posted>
  <last_update_submitted>January 3, 2023</last_update_submitted>
  <last_update_submitted_qc>January 3, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 25, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Northwestern University</investigator_affiliation>
    <investigator_full_name>David Walega</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Stelate Ganglion Block</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prostatic Neoplasms</mesh_term>
    <mesh_term>Hot Flashes</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bupivacaine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>September 16, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/95/NCT03796195/Prot_SAP_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>September 16, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/95/NCT03796195/ICF_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>.5% Bupivacaine</title>
          <description>Guided right sided stelate ganglion block using .5% bupivacaine (5mLs)&#xD;
.5% Bupivacaine: Ultrasound guided right sided stelate ganglion block using .5% bupivacaine (5mLs)</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Study closed early</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>.5% Bupivacaine</title>
          <description>Guided right sided stelate ganglion block using .5% bupivacaine (5mLs)&#xD;
.5% Bupivacaine: Ultrasound guided right sided stelate ganglion block using .5% bupivacaine (5mLs)</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="1"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="67"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Body Mass Index (kg/m^2)</title>
          <units>(kg/m^2)</units>
          <param>Number</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Baseline Hot Flash-Related Daily Interference Scale (HFRDIS)</title>
          <description>HFRIDS is a 10 question survey scored on a scale of 0=no interference and 10=high interference.&#xD;
Questions inquire about work, social activities, leisure activities,sleep, mood,concentratoin, relationship with others, sexuality,enjoyment of life and overqll quality of life. Low score=0 is the lowest interference score and the highest interference score is 100.</description>
          <units>score on a scale</units>
          <param>Number</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="48"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Baseline mean daily hot flashes</title>
          <description>Baseline mean daily hot flashes reported by subject using daily diary.</description>
          <units>Hot flashes/day</units>
          <param>Number</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="9.78"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>PROMIS SF4a Sleep Score</title>
          <description>PROMIS SF4a (sleep) Patient Reported Outcomes Measurement Information System. The PROMIS SF4a is a 4 item questionnaire that queries sleep duration, quality and interruption. This instrument accesses self reported perceptions of sleep quality. sleep depth and restoratoin associated with sleep. This includes perceived difficulties and concerns with getting to sleep or staying asleep, as well as perceptions of the adequacy of satisfaction with sleep. The 4 items are scored 1-5 where 1 is good quality and 5 is poor quality for a total score range of 4 (good quality) to 20 (poor quality).</description>
          <units>Score on a scale</units>
          <param>Number</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Hot Flash Frequency Change Baseline to 3 Months After Treatment.</title>
        <description>Change in mean daily hot flashes using a self-report hot flash diary from baseline to 3 months after stellate ganglion block.</description>
        <time_frame>3 months after SGB procedure</time_frame>
        <group_list>
          <group group_id="O1">
            <title>.5% Bupivacaine</title>
            <description>Guided right sided stelate ganglion block using .5% bupivacaine (5mLs)&#xD;
.5% Bupivacaine: Ultrasound guided right sided stelate ganglion block using .5% bupivacaine (5mLs)</description>
          </group>
        </group_list>
        <measure>
          <title>Hot Flash Frequency Change Baseline to 3 Months After Treatment.</title>
          <description>Change in mean daily hot flashes using a self-report hot flash diary from baseline to 3 months after stellate ganglion block.</description>
          <units>Hot flashes/day</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.78"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Hot Flash Severity Baseline to 3 Months After Stellate Ganglion Block</title>
        <description>The change in hot flash severity (hot flash frequency x hot flash intensity) between baseline and 3 months after SGB. Hot flash severity is determined using the mean frequency= ((Fmo+Fse))7 where FMi, Fmo and Fse are the weekly total number of mild, moderate or severe HF events. The mean severity= (Fmi+2x Fmo + 3 x Fse)/7 where FMI, Fmo and Fse are the weekly total number of mild, moderate or severe/very severe hot flash events in the case of mean severity, frequency of mild vasomotor symptoms is not counted at baseline.</description>
        <time_frame>3 months after stellate ganglion block</time_frame>
        <group_list>
          <group group_id="O1">
            <title>.5% Bupivacaine</title>
            <description>Guided right sided stelate ganglion block using .5% bupivacaine (5mLs)&#xD;
.5% Bupivacaine: Ultrasound guided right sided stelate ganglion block using .5% bupivacaine (5mLs)</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Hot Flash Severity Baseline to 3 Months After Stellate Ganglion Block</title>
          <description>The change in hot flash severity (hot flash frequency x hot flash intensity) between baseline and 3 months after SGB. Hot flash severity is determined using the mean frequency= ((Fmo+Fse))7 where FMi, Fmo and Fse are the weekly total number of mild, moderate or severe HF events. The mean severity= (Fmi+2x Fmo + 3 x Fse)/7 where FMI, Fmo and Fse are the weekly total number of mild, moderate or severe/very severe hot flash events in the case of mean severity, frequency of mild vasomotor symptoms is not counted at baseline.</description>
          <units>Score on a scale</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-55.94"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>PROMIS SF4a Score 4 Weeks After Stellate Ganglion Block.</title>
        <description>PROMIS SF4a (sleep) Patient Reportee Outcomes Measurement Information System. The PROMIS SF4a is a 4 item questionnaire that queries sleep duration, quality and interruption. This instrument accesses self reported perceptions of sleep quality, sleep depth and restoratoin associated with sleep. This includes perceived difficulties and concerns with getting to sleep or staying asleep, as well as perceptions of the adequacy and satisfaction with sleep. The 4 items are scored 1-5 where 1 is good quality and 5 is poor quality for a total score range of 4 (good quality) to 20 (poor quality).</description>
        <time_frame>4 weeks after stellate ganglion block</time_frame>
        <group_list>
          <group group_id="O1">
            <title>.5% Bupivacaine</title>
            <description>Guided right sided stelate ganglion block using .5% bupivacaine (5mLs)&#xD;
.5% Bupivacaine: Ultrasound guided right sided stelate ganglion block using .5% bupivacaine (5mLs)</description>
          </group>
        </group_list>
        <measure>
          <title>PROMIS SF4a Score 4 Weeks After Stellate Ganglion Block.</title>
          <description>PROMIS SF4a (sleep) Patient Reportee Outcomes Measurement Information System. The PROMIS SF4a is a 4 item questionnaire that queries sleep duration, quality and interruption. This instrument accesses self reported perceptions of sleep quality, sleep depth and restoratoin associated with sleep. This includes perceived difficulties and concerns with getting to sleep or staying asleep, as well as perceptions of the adequacy and satisfaction with sleep. The 4 items are scored 1-5 where 1 is good quality and 5 is poor quality for a total score range of 4 (good quality) to 20 (poor quality).</description>
          <units>Score on a scale</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Patient Global Impression of Change Score (PGIC)</title>
        <description>The PGIC assesses the participants improvement in hot flashes from the time of the stellate ganglion block to 4 weeks after the procedure. The PGIC queries how much the hot flashes have improved on a scale of 1 (very much improved) to 7 (very much worse).</description>
        <time_frame>4 weeks after stellate ganglion block</time_frame>
        <group_list>
          <group group_id="O1">
            <title>.5% Bupivacaine</title>
            <description>Guided right sided stelate ganglion block using .5% bupivacaine (5mLs)&#xD;
.5% Bupivacaine: Ultrasound guided right sided stelate ganglion block using .5% bupivacaine (5mLs)</description>
          </group>
        </group_list>
        <measure>
          <title>Patient Global Impression of Change Score (PGIC)</title>
          <description>The PGIC assesses the participants improvement in hot flashes from the time of the stellate ganglion block to 4 weeks after the procedure. The PGIC queries how much the hot flashes have improved on a scale of 1 (very much improved) to 7 (very much worse).</description>
          <units>Score on a scale</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse events were monitored for 4 weeks after stellate ganglion block procedure.</time_frame>
      <desc>Data obtained by telephone call up to 4 weeks post stellate ganglion block procedure.</desc>
      <group_list>
        <group group_id="E1">
          <title>.5% Bupivacaine</title>
          <description>Guided right sided stelate ganglion block using .5% bupivacaine (5mLs)&#xD;
.5% Bupivacaine: Ultrasound guided right sided stelate ganglion block using .5% bupivacaine (5mLs)</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>The study was closed early for slow enrollment.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>David Walega, MD</name_or_title>
      <organization>Northwestern University</organization>
      <phone>3126952500</phone>
      <email>d-walega@northwestern.edu</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03796195
org study id: STU00208657
nct id: NCT03796195
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
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.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Hot Flash Frequency Change Baseline to 3 Months After Treatment.
time frame: 3 months after SGB procedure
description: Change in mean daily hot flashes using a self-report hot flash diary from baseline to 3 months after stellate ganglion block.
measure: Change in Hot Flash Severity Baseline to 3 Months After Stellate Ganglion Block
time frame: 3 months after stellate ganglion block
description: The change in hot flash severity (hot flash frequency x hot flash intensity) between baseline and 3 months after SGB. Hot flash severity is determined using the mean frequency= ((Fmo+Fse))7 where FMi, Fmo and Fse are the weekly total number of mild, moderate or severe HF events. The mean severity= (Fmi+2x Fmo + 3 x Fse)/7 where FMI, Fmo and Fse are the weekly total number of mild, moderate or severe/very severe hot flash events in the case of mean severity, frequency of mild vasomotor symptoms is not counted at baseline.
measure: PROMIS SF4a Score 4 Weeks After Stellate Ganglion Block.
time frame: 4 weeks after stellate ganglion block
description: PROMIS SF4a (sleep) Patient Reportee Outcomes Measurement Information System. The PROMIS SF4a is a 4 item questionnaire that queries sleep duration, quality and interruption. This instrument accesses self reported perceptions of sleep quality, sleep depth and restoratoin associated with sleep. This includes perceived difficulties and concerns with getting to sleep or staying asleep, as well as perceptions of the adequacy and satisfaction with sleep. The 4 items are scored 1-5 where 1 is good quality and 5 is poor quality for a total score range of 4 (good quality) to 20 (poor quality).
measure: Patient Global Impression of Change Score (PGIC)
time frame: 4 weeks after stellate ganglion block
description: The PGIC assesses the participants improvement in hot flashes from the time of the stellate ganglion block to 4 weeks after the procedure. The PGIC queries how much the hot flashes have improved on a scale of 1 (very much improved) to 7 (very much worse).
arm group label: .5% Bupivacaine
arm group type: Experimental
description: Guided right sided stelate ganglion block using .5% bupivacaine (5mLs)
intervention type: Drug
intervention name: .5% Bupivacaine
description: Ultrasound guided right sided stelate ganglion block using .5% bupivacaine (5mLs)
arm group label: .5% Bupivacaine
other name: Right sided stelate ganglion block (SGB)
criteria: 
gender: Male
gender based: Yes
gender description: Men with prostate cancer with bothersome hot flashes.
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: David Walega, MD, MS
role: Principal Investigator
affiliation: Northwestern University
facility: 
country: United States
citation: Gonzalez BD, Small BJ, Cases MG, Williams NL, Fishman MN, Jacobsen PB, Jim HSL. Sleep disturbance in men receiving androgen deprivation therapy for prostate cancer: The role of hot flashes and nocturia. Cancer. 2018 Feb 1;124(3):499-506. doi: 10.1002/cncr.31024. Epub 2017 Oct 26.
PMID: 29072790
citation: 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 Oct;29(10):696-701. doi: 10.1016/j.clon.2017.06.009. Epub 2017 Jul 13.
PMID: 28712786
citation: Grunfeld EA, Hunter MS, Yousaf O. Men's experience of a guided self-help intervention for hot flushes associated with prostate cancer treatment. Psychol Health Med. 2017 Apr;22(4):425-433. doi: 10.1080/13548506.2016.1195504. Epub 2016 Jun 13.
PMID: 27294289
citation: Kouriefs C, Georgiou M, Ravi R. Hot flushes and prostate cancer: pathogenesis and treatment. BJU Int. 2002 Mar;89(4):379-83. doi: 10.1046/j.1464-4096.2001.01761.x. No abstract available.
PMID: 11872028
citation: 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 Sep;11(9):735-41. doi: 10.1111/j.1442-2042.2004.00896.x.
PMID: 15379937
citation: Frisk J. Managing hot flushes in men after prostate cancer--a systematic review. Maturitas. 2010 Jan;65(1):15-22. doi: 10.1016/j.maturitas.2009.10.017. Epub 2009 Dec 4.
PMID: 19962840
citation: Trump DL. Commentary on "association of androgen deprivation therapy with cardiovascular death in patients with prostate cancer: a meta-analysis of randomized trials." Nguyen PL, Je Y, Schutz FA, Hoffman KE, Hu JC, Parekh A, Beckman JA, Choueiri TK, Department of Radiation Oncology, Dana-Farber Cancer Institute, Brigham and Women's Hospital, 75 Francis Street, Boston, MA 02115, USA: JAMA 2011;306(21):2359-66. Urol Oncol. 2012 Sep;30(5):746-7. doi: 10.1016/j.urolonc.2012.06.007. No abstract available.
PMID: 23021559
citation: Gavin AT, Donnelly D, Donnelly C, Drummond FJ, Morgan E, Gormley GJ, Sharp L. Effect of investigation intensity and treatment differences on prostate cancer survivor's physical symptoms, psychological well-being and health-related quality of life: a two country cross-sectional study. BMJ Open. 2016 Dec 19;6(12):e012952. doi: 10.1136/bmjopen-2016-012952. Erratum In: BMJ Open. 2017 Jan 23;7(1):e012952corr1.
PMID: 27993906
citation: Eziefula CU, Grunfeld EA, Hunter MS. 'You know I've joined your club... I'm the hot flush boy': a qualitative exploration of hot flushes and night sweats in men undergoing androgen deprivation therapy for prostate cancer. Psychooncology. 2013 Dec;22(12):2823-30. doi: 10.1002/pon.3355. Epub 2013 Jul 28.
PMID: 23893467
responsible party type: Principal Investigator
investigator affiliation: Northwestern University
investigator full name: David Walega
investigator title: Principal Investigator
mesh term: Prostatic Neoplasms
mesh term: Hot Flashes
mesh term: Bupivacaine
sharing ipd: No
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: The study was closed early for slow enrollment.
point of contact: 