<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/NCT03813615</url>
  </required_header>
  <id_info>
    <org_study_id>18-534</org_study_id>
    <nct_id>NCT03813615</nct_id>
  </id_info>
  <brief_title>Study of the Effects of Pre-surgical Aerobic Exercise on Patients With Solid Tumors</brief_title>
  <official_title>Preoperative Aerobic Training for Solid Tumors (PRESTO 1): A Phase 0/1a Digitized Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Memorial Sloan Kettering Cancer Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Memorial Sloan Kettering Cancer Center</source>
  <oversight_info>
    <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 study is to find the safest level of aerobic training for people about to&#xD;
      undergo surgery for their cancer, and to learn what effects, if any, aerobic exercise has on&#xD;
      these patients and the outcomes of their cancers. This part of the study (Phase 0) will&#xD;
      evaluate the feasibility and quality of at-home exercise and assessment procedures and find&#xD;
      out whether study participants are willing to practice continuous lifestyle monitoring using&#xD;
      apps and electronic devices.&#xD;
&#xD;
      Phase 1a will compare the effects and feasibility of six different doses of aerobic exercise&#xD;
      and will continue evaluating the quality of at-home study procedures, which includes the use&#xD;
      of continuous lifestyle monitoring through apps and electronic devices.&#xD;
&#xD;
      In order to facilitate completion of the phase 1a component, we will backfill the 90, 225,&#xD;
      and 300 mins/wk dosing cohorts with at least 4 patients in each dose cohort.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">January 21, 2019</start_date>
  <completion_date type="Anticipated">January 2025</completion_date>
  <primary_completion_date type="Anticipated">January 2025</primary_completion_date>
  <phase>Early Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Sequential Assignment</intervention_model>
    <intervention_model_description>This protocol is a single-center, open-label, phase 0 / 1 a/b study of preoperative aerobic training in patients with untreated solid tumors. This study design allows for the enrollment of patients with various types of cancer. This study will target patients with prespecified solid malignancies.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>identify the recommended dose of aerobic training</measure>
    <time_frame>1 year</time_frame>
    <description>The relative dose intensity is defined as the ratio of completed to planned aerobic training dose continually assessed at the end of the intervention period.49 Hence, the maximal feasible dose is defined as the highest dose at which &lt;30% of patients in a dosing cohort fail to achieve the target total cumulative relative dose intensity.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">84</enrollment>
  <condition>Preoperative Aerobic Training</condition>
  <condition>Solid Tumors</condition>
  <arm_group>
    <arm_group_label>Pilot &quot;Proof-of-Concept&quot;</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Individualized, progressive aerobic training consisting of treadmill walking for a total of 150 mins/wk delivered over 5 sessions/wk following a linear (breast, prostate, and endometrial) or non-linear (lung) dosing schedule for a minimum of 2 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Phase 1a: Dose-Finding / Escalation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Individualized, progressive aerobic training consisting of treadmill walking ranging from a total of 90 mins/wk to 450 mins/wk delivered over 3 to 7 sessions/wk following a linear or non-linear dosing schedule for a minimum of 2 weeks. If a patient is temporarily unable to complete supervised sessions as a result of unforeseen circumstances, patients may be assigned low intensity unsupervised training sessions per EP/PI discretion.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>treadmill walking (Proof-of-Concept)</intervention_name>
    <description>Individualized, progressive aerobic training consisting of treadmill walking for a total of 150 mins/wk delivered over 5 sessions/wk following a linear dosing schedule for a minimum of 2 weeks. All aerobic training treatment will be implemented and may be monitored using TeleEx. Participants may also perform up to two aerobic training sessions per week in an unsupervised home-based setting. Patients will be provided with Appendix J - Unsupervised Home-Based Exercise Recording Form and Appendix K - Unsupervised Home-Based Exercise Instructions to record their sessions. General physical activity as well as exercise performed outside of the structured treatment sessions will be evaluated via continuous monitoring using MSK approved telemedicine / wireless technology. setting.</description>
    <arm_group_label>Pilot &quot;Proof-of-Concept&quot;</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>treadmill walking Dose-Finding / Escalation</intervention_name>
    <description>Six doses of aerobic training ( 90mins/wk, 150 mins/wk, 225 mins/wk, 300 mins/wk &amp; 450mins/wk) delivered following either a standard linear (i.e., each dose of exercise is performed at the same intensity &amp; duration) or non-linear (i.e., exercise dose is continually altered &amp; progressed in conjunction with appropriate rest/recovery sessions across the entire intervention period) dosing schedule 3 to 6 times weekly (over a 7-day period) for a minimum 2 weeks. Aerobic training treatment will be implemented &amp; may be monitored using TeleEx. Patients may also perform up to three aerobic training sessions per week in an unsupervised home-based setting. Patients will be provided a plan for their unsupervised session(s) verbally or via Portal Secure Messaging (PSM), as appropriate.</description>
    <arm_group_label>Phase 1a: Dose-Finding / Escalation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Phase 0 (Proof-of-Concept)&#xD;
&#xD;
          -  Patients with one of the following:&#xD;
&#xD;
               -  Early-stage breast cancer having completed participation in IRB# 15-147&#xD;
&#xD;
               -  Diagnosed with the prespecified solid tumors: endometrial, breast or prostate&#xD;
                  cancer&#xD;
&#xD;
               -  Underwent a diagnostic lung biopsy within 14 days prior to enrollment&#xD;
&#xD;
               -  Age &gt;18 years&#xD;
&#xD;
               -  BMI ≤ 40&#xD;
&#xD;
               -  Has ≥ 20 mg of fresh normal lung and suspicious lung tissue from the standard of&#xD;
                  care diagnostic biopsy available for snap freezing and single-cell sequencing&#xD;
                  (lung patients only)&#xD;
&#xD;
               -  At least a 2-week window from study enrollment to scheduled surgical resection&#xD;
                  (patients with prespecified solid tumors only)&#xD;
&#xD;
               -  Performing less than 30 minutes of structured moderate-intensity or&#xD;
                  strenuous-intensity exercise per week, as evaluation by self report If &gt; 30&#xD;
                  minutes but less than 90 minutes, patients may be eligible, at the discretion of&#xD;
                  the PI.&#xD;
&#xD;
               -  Cleared for exercise participation as per screening clearance via PAR-Q+&#xD;
&#xD;
               -  Willingness to comply with all study-related procedures&#xD;
&#xD;
        Phase 1a (Dose-Finding/Escalation)&#xD;
&#xD;
          -  Patients with operable untreated prostate cancer scheduled for surgery&#xD;
&#xD;
          -  At least a 2-week window from study enrollment to scheduled surgical resection&#xD;
             (patients with prespecified solid tumors only)&#xD;
&#xD;
          -  Age &gt; 18 years&#xD;
&#xD;
          -  BMI &lt;/=40&#xD;
&#xD;
          -  If BMI &gt;40, patients may be eligible, at the discretion of the PI&#xD;
&#xD;
          -  Performing &lt;/= 30 minutes of structured moderate-intensity or strenuous-intensity&#xD;
             exercise per week, as evaluation by self report If &gt; 30 minutes but less than 90&#xD;
             minutes, patients may be eligible, at the discretion of the PI.&#xD;
&#xD;
          -  Cleared for exercise participation as per screening clearance via PAR-Q+&#xD;
&#xD;
          -  Willingness to comply with all study-related procedures&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Use of any selective estrogen receptor modulator or aromatase inhibitor within 6&#xD;
             months of study entry, including, but not limited to: tamoxifen, raloxifene,&#xD;
             arzoxifene, acolbifene, anastrozole, exemestane, and letrozole (for preoperative&#xD;
             breast, endometrial, and prostate patients in Phase 0 only)&#xD;
&#xD;
          -  Enrollment onto any other interventional investigational study except interventions&#xD;
             determined by the PI not to confound the effect of exercise on study outcomes&#xD;
&#xD;
          -  Men receiving GNRH agonists and antagonists as well as any antiandrogrens&#xD;
&#xD;
          -  Any neoadjuvant anticancer treatment of any kind for the cancer of interest&#xD;
&#xD;
          -  Any history of systemic anticancer therapy&#xD;
&#xD;
          -  Any other diagnosis of invasive cancer currently requiring active treatment&#xD;
&#xD;
          -  Metastatic malignancy of any kind&#xD;
&#xD;
          -  Any other condition or intercurrent illness that, in the opinion of the investigator,&#xD;
             makes the subject a poor candidate for study participation.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lee W. Jones, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Memorial Sloan Kettering Cancer Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Lee W. Jones, PhD</last_name>
    <phone>646-888-8103</phone>
    <email>jonesl3@mskcc.org</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Jessica Scott, PhD</last_name>
    <phone>646-888-8093</phone>
    <email>scottj1@mskcc.org</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>University of California, Los Angeles (Data Analysis only)</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90095</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Paul C Boutros, PhD</last_name>
      <phone>310-794-7160</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)</name>
      <address>
        <city>Basking Ridge</city>
        <state>New Jersey</state>
        <zip>07920</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Lee Jones, PhD</last_name>
      <phone>646-888-8103</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Monmouth (Limited Protocol Activities)</name>
      <address>
        <city>Middletown</city>
        <state>New Jersey</state>
        <zip>07748</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Lee Jones, PhD</last_name>
      <phone>646-888-8103</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Bergen (Limited Protocol Activities)</name>
      <address>
        <city>Montvale</city>
        <state>New Jersey</state>
        <zip>07645</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Lee Jones, PhD</last_name>
      <phone>646-888-8103</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Commack (Limited Protocol Activities)</name>
      <address>
        <city>Commack</city>
        <state>New York</state>
        <zip>11725</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Lee Jones, PhD</last_name>
      <phone>646-888-8103</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Westchester (Limited Protocol Activities)</name>
      <address>
        <city>Harrison</city>
        <state>New York</state>
        <zip>10604</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Lee Jones, PhD</last_name>
      <phone>646-888-8103</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Cancer Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10065</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Lee Jones, PhD</last_name>
      <phone>646-888-8103</phone>
    </contact>
    <contact_backup>
      <last_name>David Hyman, MD</last_name>
      <phone>646-888-4544</phone>
    </contact_backup>
    <investigator>
      <last_name>Lee Jones, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Nassau (Limited Protocol Activities)</name>
      <address>
        <city>Uniondale</city>
        <state>New York</state>
        <zip>11553</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Lee Jones, PhD</last_name>
      <phone>646-888-8103</phone>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.mskcc.org/mskcc/html/44.cfm</url>
    <description>Memorial Sloan Kettering Cancer Center</description>
  </link>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>January 21, 2019</study_first_submitted>
  <study_first_submitted_qc>January 21, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 23, 2019</study_first_posted>
  <last_update_submitted>August 1, 2023</last_update_submitted>
  <last_update_submitted_qc>August 1, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 2, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Aerobic Training</keyword>
  <keyword>18-534</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made following one year after publication and for up to 36 months later. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.</ipd_description>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT03813615
org study id: 18-534
nct id: NCT03813615
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to find the safest level of aerobic training for people about to
      undergo surgery for their cancer, and to learn what effects, if any, aerobic exercise has on
      these patients and the outcomes of their cancers. This part of the study (Phase 0) will
      evaluate the feasibility and quality of at-home exercise and assessment procedures and find
      out whether study participants are willing to practice continuous lifestyle monitoring using
      apps and electronic devices.

      Phase 1a will compare the effects and feasibility of six different doses of aerobic exercise
      and will continue evaluating the quality of at-home study procedures, which includes the use
      of continuous lifestyle monitoring through apps and electronic devices.

      In order to facilitate completion of the phase 1a component, we will backfill the 90, 225,
      and 300 mins/wk dosing cohorts with at least 4 patients in each dose cohort.
allocation: Non-Randomized
intervention model: Sequential Assignment
intervention model description: This protocol is a single-center, open-label, phase 0 / 1 a/b study of preoperative aerobic training in patients with untreated solid tumors. This study design allows for the enrollment of patients with various types of cancer. This study will target patients with prespecified solid malignancies.
primary purpose: Treatment
masking: None (Open Label)
measure: identify the recommended dose of aerobic training
time frame: 1 year
description: The relative dose intensity is defined as the ratio of completed to planned aerobic training dose continually assessed at the end of the intervention period.49 Hence, the maximal feasible dose is defined as the highest dose at which <30% of patients in a dosing cohort fail to achieve the target total cumulative relative dose intensity.
arm group label: Pilot "Proof-of-Concept"
arm group type: Experimental
description: Individualized, progressive aerobic training consisting of treadmill walking for a total of 150 mins/wk delivered over 5 sessions/wk following a linear (breast, prostate, and endometrial) or non-linear (lung) dosing schedule for a minimum of 2 weeks.
arm group label: Phase 1a: Dose-Finding / Escalation
arm group type: Experimental
description: Individualized, progressive aerobic training consisting of treadmill walking ranging from a total of 90 mins/wk to 450 mins/wk delivered over 3 to 7 sessions/wk following a linear or non-linear dosing schedule for a minimum of 2 weeks. If a patient is temporarily unable to complete supervised sessions as a result of unforeseen circumstances, patients may be assigned low intensity unsupervised training sessions per EP/PI discretion.
intervention type: Behavioral
intervention name: treadmill walking (Proof-of-Concept)
description: Individualized, progressive aerobic training consisting of treadmill walking for a total of 150 mins/wk delivered over 5 sessions/wk following a linear dosing schedule for a minimum of 2 weeks. All aerobic training treatment will be implemented and may be monitored using TeleEx. Participants may also perform up to two aerobic training sessions per week in an unsupervised home-based setting. Patients will be provided with Appendix J - Unsupervised Home-Based Exercise Recording Form and Appendix K - Unsupervised Home-Based Exercise Instructions to record their sessions. General physical activity as well as exercise performed outside of the structured treatment sessions will be evaluated via continuous monitoring using MSK approved telemedicine / wireless technology. setting.
arm group label: Pilot "Proof-of-Concept"
intervention type: Behavioral
intervention name: treadmill walking Dose-Finding / Escalation
description: Six doses of aerobic training ( 90mins/wk, 150 mins/wk, 225 mins/wk, 300 mins/wk & 450mins/wk) delivered following either a standard linear (i.e., each dose of exercise is performed at the same intensity & duration) or non-linear (i.e., exercise dose is continually altered & progressed in conjunction with appropriate rest/recovery sessions across the entire intervention period) dosing schedule 3 to 6 times weekly (over a 7-day period) for a minimum 2 weeks. Aerobic training treatment will be implemented & may be monitored using TeleEx. Patients may also perform up to three aerobic training sessions per week in an unsupervised home-based setting. Patients will be provided a plan for their unsupervised session(s) verbally or via Portal Secure Messaging (PSM), as appropriate.
arm group label: Phase 1a: Dose-Finding / Escalation
criteria: 
gender: All
minimum age: 19 Years
maximum age: N/A
healthy volunteers: No
last name: Lee W. Jones, PhD
role: Principal Investigator
affiliation: Memorial Sloan Kettering Cancer Center
last name: Lee W. Jones, PhD
phone: 646-888-8103
email: jonesl3@mskcc.org
last name: Jessica Scott, PhD
phone: 646-888-8093
email: scottj1@mskcc.org
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
facility: 
status: Recruiting
contact: 
country: United States
url: http://www.mskcc.org/mskcc/html/44.cfm
description: Memorial Sloan Kettering Cancer Center
responsible party type: Sponsor
mesh term: Neoplasms
sharing ipd: Yes
ipd description: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made following one year after publication and for up to 36 months later. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)