xml: <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/NCT06008977</url>
    </required_header>
    <id_info>
      <org_study_id>1805426</org_study_id>
      <nct_id>NCT06008977</nct_id>
    </id_info>
    <brief_title>Exercise to Boost Response to Checkpoint Blockade Immunotherapy</brief_title>
    <acronym>EX-BOOST</acronym>
    <official_title>Exercise to Boost Response to Checkpoint Blockade Immunotherapy</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>AdventHealth Translational Research Institute</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>AdventHealth Translational Research Institute</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The purpose of this pilot study will be to provide i) information on feasibility implementing&#xD;
        an exercise intervention trial among patients with cutaneous cancers, including melanoma,&#xD;
        squamous cell carcinoma (cuSCC), and Merkel cell carcinoma, scheduled to receive checkpoint&#xD;
        blockade immunotherapy, and ii) preliminary data on the impact of a day-of-therapy exercise&#xD;
        intervention.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">May 2025</completion_date>
    <primary_completion_date type="Anticipated">May 2025</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <intervention_model_description>We will use stratified block randomization to assure non-biased assignment to the exercise intervention arm. Within each treatment setting, adjuvant and neoadjuvant, 10 patients will be randomized to the exercise intervention arm and 10 to the standard treatment arm. Within the neoadjuvant setting, randomization also will be blocked within disease type.</intervention_model_description>
      <primary_purpose>Other</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Relapse-free survival</measure>
      <time_frame>Up to 12 months</time_frame>
      <description>For patients treated in the adjuvant setting. Total study duration is dependent upon oncology therapy.&#xD;
  Recurrence-free survival will be assessed.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Pathological complete response (pCR)</measure>
      <time_frame>Up to 12 months</time_frame>
      <description>For patients treated in the neoadjuvant setting. All neoadjuvant patients will have remaining tumor and, when appropriate, its associated nodal basin removed after completion of checkpoint blockade immunotherapy. Total study duration is dependent upon oncology therapy.&#xD;
  This will be measured in excised tissues after standard-of-care surgery post completion of checkpoint blockade immunotherapy.</description>
    </primary_outcome>
    <number_of_arms>4</number_of_arms>
    <enrollment type="Anticipated">20</enrollment>
    <condition>Cutaneous Melanoma</condition>
    <condition>Cutaneous Squamous Cell Carcinoma</condition>
    <condition>Merkel Cell Carcinoma</condition>
    <arm_group>
      <arm_group_label>Standard Group- No Exercise (Adjuvant)</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Patients randomized to the standard arm will receive clinical care following AH standards for the patient's disease type and therapeutic setting. This includes history and physical and laboratory studies to be conducted on each infusion day before clearing the patient for infusion.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Intervention Group- Moderate Exercise (adjuvant)</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Patients randomized to the exercise arm will complete up to 30 minutes of same-day exercise prior to each administration of checkpoint blockade immunotherapy across all cycles. The preferred exercise is 30 minutes of moderate exertion on a cycle ergometer.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Standard Group- No Exercise (Neoadjuvant)</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Patients randomized to the standard arm will receive clinical care following AH (AdventHealth) standards for the patient's disease type and therapeutic setting. This includes history and physical and laboratory studies to be conducted on each infusion day before clearing the patient for infusion.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Intervention Group- Moderate Exercise (Neoadjuvant)</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Patients randomized to the exercise arm will complete up to 30 minutes of same-day exercise prior to each administration of checkpoint blockade immunotherapy across all cycles. The preferred exercise is 30 minutes of moderate exertion on a cycle ergometer.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Exercise Test</intervention_name>
      <description>Supervised pedaling on an ergometer (stationary bike) at a moderate pace for a goal of 30 minutes. The exercise test will be scheduled at infusion visits 1, 6, and 12 or 1 and 3 over the treatment cycle, depending on the group assignment.</description>
      <arm_group_label>Intervention Group- Moderate Exercise (Neoadjuvant)</arm_group_label>
      <arm_group_label>Intervention Group- Moderate Exercise (adjuvant)</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Males and females ≥18 years of age.&#xD;
  &#xD;
            2. Able to read and speak English fluently.&#xD;
  &#xD;
            3. Reported ability to complete 20-30 minutes moderate exercise per positive response to,&#xD;
               &quot;Can you currently walk unaided for six minutes or more?&quot;&#xD;
  &#xD;
            4. Scheduled for first-time checkpoint blockade immunotherapy with avelumab, cemiplimab,&#xD;
               ipilimumab, nivolumab, or pembrolizumab in the absence of other therapies (e.g.&#xD;
               targeted therapy) with the following diagnosis:&#xD;
  &#xD;
                 1. Adjuvant setting: cutaneous melanoma.&#xD;
  &#xD;
                 2. Neoadjuvant setting: cutaneous melanoma, cuSCC, or Merkel cell carcinoma.&#xD;
  &#xD;
            5. States willingness to follow protocol as described, including the prescribed exercise&#xD;
               level and completing any forms needed throughout the study.&#xD;
  &#xD;
            6. Voluntarily signed and dated an informed consent form, approved by an Institutional&#xD;
               Review Board/Independent Ethics Committee, and provided Health Insurance Portability&#xD;
               and Accountability Act authorization (HIPAA) or other privacy authorization prior to&#xD;
               any participation in study.&#xD;
  &#xD;
               Exclusion Criteria:&#xD;
  &#xD;
            7. Presence of medical conditions, such as severe cardiovascular disease for which&#xD;
               exercise may be contraindicated. Participants may be referred to their medical team to&#xD;
               obtain a cardiology approval.&#xD;
  &#xD;
            8. Presence of major postoperative complications for which an exercise intervention may&#xD;
               be contraindicated.&#xD;
  &#xD;
            9. Currently has a chronic, contagious, infectious disease, such as active tuberculosis,&#xD;
               active Hepatitis B or C, HIV, or COVID-19, per self-report.&#xD;
  &#xD;
           10. Currently pregnant, lactating or planning to become pregnant (positive result on urine&#xD;
               pregnancy testing).&#xD;
  &#xD;
           11. Presence of any condition that, in the opinion of the Investigator, compromises&#xD;
               participant safety or data integrity or the participant's ability to complete the&#xD;
               study.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Bret Goodpaster, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Study Principal Investigator</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Recruitment Department</last_name>
      <phone>407-303-7100</phone>
      <email>Fh.tri.recruitment@adventhealth.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>AdventHealth Translational Research Institute</name>
        <address>
          <city>Orlando</city>
          <state>Florida</state>
          <zip>32804</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Recruitment Department</last_name>
        <phone>407-303-7100</phone>
        <email>Fh.tri.recruitment@adventhealth.com</email>
      </contact>
      <investigator>
        <last_name>Bret Goodpaster, PhD</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Tarek Mekhail, MD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <link>
      <url>https://www.adventhealthresearchinstitute.com/research/translational-research</url>
      <description>Website for AdventHealth Translational Research Institute</description>
    </link>
    <reference>
      <citation>Hojman P, Gehl J, Christensen JF, Pedersen BK. Molecular Mechanisms Linking Exercise to Cancer Prevention and Treatment. Cell Metab. 2018 Jan 9;27(1):10-21. doi: 10.1016/j.cmet.2017.09.015. Epub 2017 Oct 19.</citation>
      <PMID>29056514</PMID>
    </reference>
    <reference>
      <citation>Campbell JP, Turner JE. Debunking the Myth of Exercise-Induced Immune Suppression: Redefining the Impact of Exercise on Immunological Health Across the Lifespan. Front Immunol. 2018 Apr 16;9:648. doi: 10.3389/fimmu.2018.00648. eCollection 2018.</citation>
      <PMID>29713319</PMID>
    </reference>
    <reference>
      <citation>Martin-Ruiz A, Fiuza-Luces C, Rincon-Castanedo C, Fernandez-Moreno D, Galvez BG, Martinez-Martinez E, Martin-Acosta P, Coronado MJ, Franco-Luzon L, Gonzalez-Murillo A, Ramirez M, Provencio M, Lucia A. Benefits of exercise and immunotherapy in a murine model of human non-small-cell lung carcinoma. Exerc Immunol Rev. 2020;26:100-115.</citation>
      <PMID>32139351</PMID>
    </reference>
    <reference>
      <citation>Montes J, McDermott MP, Martens WB, Dunaway S, Glanzman AM, Riley S, Quigley J, Montgomery MJ, Sproule D, Tawil R, Chung WK, Darras BT, De Vivo DC, Kaufmann P, Finkel RS; Muscle Study Group and the Pediatric Neuromuscular Clinical Research Network. Six-Minute Walk Test demonstrates motor fatigue in spinal muscular atrophy. Neurology. 2010 Mar 9;74(10):833-8. doi: 10.1212/WNL.0b013e3181d3e308.</citation>
      <PMID>20211907</PMID>
    </reference>
    <reference>
      <citation>Tetzlaff MT, Messina JL, Stein JE, Xu X, Amaria RN, Blank CU, van de Wiel BA, Ferguson PM, Rawson RV, Ross MI, Spillane AJ, Gershenwald JE, Saw RPM, van Akkooi ACJ, van Houdt WJ, Mitchell TC, Menzies AM, Long GV, Wargo JA, Davies MA, Prieto VG, Taube JM, Scolyer RA. Pathological assessment of resection specimens after neoadjuvant therapy for metastatic melanoma. Ann Oncol. 2018 Aug 1;29(8):1861-1868. doi: 10.1093/annonc/mdy226.</citation>
      <PMID>29945191</PMID>
    </reference>
    <reference>
      <citation>Weber J, Mandala M, Del Vecchio M, Gogas HJ, Arance AM, Cowey CL, Dalle S, Schenker M, Chiarion-Sileni V, Marquez-Rodas I, Grob JJ, Butler MO, Middleton MR, Maio M, Atkinson V, Queirolo P, Gonzalez R, Kudchadkar RR, Smylie M, Meyer N, Mortier L, Atkins MB, Long GV, Bhatia S, Lebbe C, Rutkowski P, Yokota K, Yamazaki N, Kim TM, de Pril V, Sabater J, Qureshi A, Larkin J, Ascierto PA; CheckMate 238 Collaborators. Adjuvant Nivolumab versus Ipilimumab in Resected Stage III or IV Melanoma. N Engl J Med. 2017 Nov 9;377(19):1824-1835. doi: 10.1056/NEJMoa1709030. Epub 2017 Sep 10.</citation>
      <PMID>28891423</PMID>
    </reference>
    <reference>
      <citation>Khunger A, Buchwald ZS, Lowe M, Khan MK, Delman KA, Tarhini AA. Neoadjuvant therapy of locally/regionally advanced melanoma. Ther Adv Med Oncol. 2019 Jul 31;11:1758835919866959. doi: 10.1177/1758835919866959. eCollection 2019.</citation>
      <PMID>31391869</PMID>
    </reference>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>June 6, 2023</study_first_submitted>
    <study_first_submitted_qc>August 18, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 24, 2023</study_first_posted>
    <last_update_submitted>September 11, 2023</last_update_submitted>
    <last_update_submitted_qc>September 11, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Carcinoma, Merkel Cell</mesh_term>
      <mesh_term>Carcinoma</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06008977
  org study id: 1805426
  nct id: NCT06008977
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The purpose of this pilot study will be to provide i) information on feasibility implementing
        an exercise intervention trial among patients with cutaneous cancers, including melanoma,
        squamous cell carcinoma (cuSCC), and Merkel cell carcinoma, scheduled to receive checkpoint
        blockade immunotherapy, and ii) preliminary data on the impact of a day-of-therapy exercise
        intervention.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: We will use stratified block randomization to assure non-biased assignment to the exercise intervention arm. Within each treatment setting, adjuvant and neoadjuvant, 10 patients will be randomized to the exercise intervention arm and 10 to the standard treatment arm. Within the neoadjuvant setting, randomization also will be blocked within disease type.
  primary purpose: Other
  masking: None (Open Label)
  measure: Relapse-free survival
  time frame: Up to 12 months
  description: For patients treated in the adjuvant setting. Total study duration is dependent upon oncology therapy.
  Recurrence-free survival will be assessed.
  measure: Pathological complete response (pCR)
  time frame: Up to 12 months
  description: For patients treated in the neoadjuvant setting. All neoadjuvant patients will have remaining tumor and, when appropriate, its associated nodal basin removed after completion of checkpoint blockade immunotherapy. Total study duration is dependent upon oncology therapy.
  This will be measured in excised tissues after standard-of-care surgery post completion of checkpoint blockade immunotherapy.
  arm group label: Standard Group- No Exercise (Adjuvant)
  arm group type: No Intervention
  description: Patients randomized to the standard arm will receive clinical care following AH standards for the patient's disease type and therapeutic setting. This includes history and physical and laboratory studies to be conducted on each infusion day before clearing the patient for infusion.
  arm group label: Intervention Group- Moderate Exercise (adjuvant)
  arm group type: Active Comparator
  description: Patients randomized to the exercise arm will complete up to 30 minutes of same-day exercise prior to each administration of checkpoint blockade immunotherapy across all cycles. The preferred exercise is 30 minutes of moderate exertion on a cycle ergometer.
  arm group label: Standard Group- No Exercise (Neoadjuvant)
  arm group type: No Intervention
  description: Patients randomized to the standard arm will receive clinical care following AH (AdventHealth) standards for the patient's disease type and therapeutic setting. This includes history and physical and laboratory studies to be conducted on each infusion day before clearing the patient for infusion.
  arm group label: Intervention Group- Moderate Exercise (Neoadjuvant)
  arm group type: Active Comparator
  description: Patients randomized to the exercise arm will complete up to 30 minutes of same-day exercise prior to each administration of checkpoint blockade immunotherapy across all cycles. The preferred exercise is 30 minutes of moderate exertion on a cycle ergometer.
  intervention type: Other
  intervention name: Exercise Test
  description: Supervised pedaling on an ergometer (stationary bike) at a moderate pace for a goal of 30 minutes. The exercise test will be scheduled at infusion visits 1, 6, and 12 or 1 and 3 over the treatment cycle, depending on the group assignment.
  arm group label: Intervention Group- Moderate Exercise (Neoadjuvant)
  arm group label: Intervention Group- Moderate Exercise (adjuvant)
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Bret Goodpaster, PhD
  role: Principal Investigator
  affiliation: Study Principal Investigator
  last name: Recruitment Department
  phone: 407-303-7100
  email: Fh.tri.recruitment@adventhealth.com
  facility: 
  contact: 
  investigator: 
  investigator: 
  country: United States
  url: https://www.adventhealthresearchinstitute.com/research/translational-research
  description: Website for AdventHealth Translational Research Institute
  citation: Hojman P, Gehl J, Christensen JF, Pedersen BK. Molecular Mechanisms Linking Exercise to Cancer Prevention and Treatment. Cell Metab. 2018 Jan 9;27(1):10-21. doi: 10.1016/j.cmet.2017.09.015. Epub 2017 Oct 19.
  PMID: 29056514
  citation: Campbell JP, Turner JE. Debunking the Myth of Exercise-Induced Immune Suppression: Redefining the Impact of Exercise on Immunological Health Across the Lifespan. Front Immunol. 2018 Apr 16;9:648. doi: 10.3389/fimmu.2018.00648. eCollection 2018.
  PMID: 29713319
  citation: Martin-Ruiz A, Fiuza-Luces C, Rincon-Castanedo C, Fernandez-Moreno D, Galvez BG, Martinez-Martinez E, Martin-Acosta P, Coronado MJ, Franco-Luzon L, Gonzalez-Murillo A, Ramirez M, Provencio M, Lucia A. Benefits of exercise and immunotherapy in a murine model of human non-small-cell lung carcinoma. Exerc Immunol Rev. 2020;26:100-115.
  PMID: 32139351
  citation: Montes J, McDermott MP, Martens WB, Dunaway S, Glanzman AM, Riley S, Quigley J, Montgomery MJ, Sproule D, Tawil R, Chung WK, Darras BT, De Vivo DC, Kaufmann P, Finkel RS; Muscle Study Group and the Pediatric Neuromuscular Clinical Research Network. Six-Minute Walk Test demonstrates motor fatigue in spinal muscular atrophy. Neurology. 2010 Mar 9;74(10):833-8. doi: 10.1212/WNL.0b013e3181d3e308.
  PMID: 20211907
  citation: Tetzlaff MT, Messina JL, Stein JE, Xu X, Amaria RN, Blank CU, van de Wiel BA, Ferguson PM, Rawson RV, Ross MI, Spillane AJ, Gershenwald JE, Saw RPM, van Akkooi ACJ, van Houdt WJ, Mitchell TC, Menzies AM, Long GV, Wargo JA, Davies MA, Prieto VG, Taube JM, Scolyer RA. Pathological assessment of resection specimens after neoadjuvant therapy for metastatic melanoma. Ann Oncol. 2018 Aug 1;29(8):1861-1868. doi: 10.1093/annonc/mdy226.
  PMID: 29945191
  citation: Weber J, Mandala M, Del Vecchio M, Gogas HJ, Arance AM, Cowey CL, Dalle S, Schenker M, Chiarion-Sileni V, Marquez-Rodas I, Grob JJ, Butler MO, Middleton MR, Maio M, Atkinson V, Queirolo P, Gonzalez R, Kudchadkar RR, Smylie M, Meyer N, Mortier L, Atkins MB, Long GV, Bhatia S, Lebbe C, Rutkowski P, Yokota K, Yamazaki N, Kim TM, de Pril V, Sabater J, Qureshi A, Larkin J, Ascierto PA; CheckMate 238 Collaborators. Adjuvant Nivolumab versus Ipilimumab in Resected Stage III or IV Melanoma. N Engl J Med. 2017 Nov 9;377(19):1824-1835. doi: 10.1056/NEJMoa1709030. Epub 2017 Sep 10.
  PMID: 28891423
  citation: Khunger A, Buchwald ZS, Lowe M, Khan MK, Delman KA, Tarhini AA. Neoadjuvant therapy of locally/regionally advanced melanoma. Ther Adv Med Oncol. 2019 Jul 31;11:1758835919866959. doi: 10.1177/1758835919866959. eCollection 2019.
  PMID: 31391869
  responsible party type: Sponsor
  mesh term: Carcinoma, Merkel Cell
  mesh term: Carcinoma