<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/NCT03280836</url>
  </required_header>
  <id_info>
    <org_study_id>5517</org_study_id>
    <nct_id>NCT03280836</nct_id>
  </id_info>
  <brief_title>Exercise Program in Breast Cancer Patients Receiving Neoadjuvant Chemotherapy</brief_title>
  <acronym>WISER-NET</acronym>
  <official_title>Women In Steady Exercise Research - Neoadjuvant Exercise Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Milton S. Hershey Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>NRG Oncology</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Milton S. Hershey Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</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 investigators seek to conduct a home based exercise intervention in breast cancer&#xD;
      patients whom elect to undergo neoadjuvant chemotherapy. The primary aim of the study is to&#xD;
      determine whether breast cancer patients can be enrolled, randomized, retained, and comply&#xD;
      with exercise program; and, the feasibility of acquiring, managing and analyzing clinical&#xD;
      data.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Several national and international agencies recommend exercise participation for all persons&#xD;
      following a cancer diagnosis. The current evidence suggests that aerobic exercise training is&#xD;
      safe during primary adjuvant therapy and improves cardiopulmonary function and patient&#xD;
      related outcomes. Cardiopulmonary fitness is highly predictive of overall and cardiovascular&#xD;
      specific mortality in women. Specifically, an increase in cardiopulmonary fitness of&#xD;
      approximately 10% has been associated with a 19% reduction in risk for CV mortality. This is&#xD;
      important as breast cancer patients already present at diagnosis with 31% lower&#xD;
      cardiopulmonary fitness levels compared to healthy age-matched women. This enhanced risk for&#xD;
      cardiovascular mortality in breast cancer patients is further compounded by cardiotoxic&#xD;
      chemotherapy, which causes permanent cardiac damage. Few studies have tested the efficacy of&#xD;
      exercise prescriptions that incorporate high intensity aerobic exercise training in cancer&#xD;
      patients, especially those receiving chemotherapy. Therefore, the investigators seek to&#xD;
      conduct an at home aerobic exercise training intervention in breast cancer patients whom&#xD;
      elect to undergo neoadjuvant chemotherapy&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 3, 2017</start_date>
  <completion_date type="Actual">December 21, 2020</completion_date>
  <primary_completion_date type="Actual">December 21, 2020</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>Participants are randomized to the intervention or control arm.</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Double (Care Provider, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Acceptability: Percent of Eligible Patients That Provide Consent and Are Enrolled in the Study.</measure>
    <time_frame>4 weeks</time_frame>
    <description>Acceptability of the study will be assessed by documenting the percent of eligible patients that provide consent and are enrolled in the study.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Participant Adherence to the Exercise Intervention</measure>
    <time_frame>Introduction phase of prescribed exercise training (weeks 1-4), intermediate phase of prescribed exercise training (weeks 5-11), maintenance phase of prescribed exercise training (weeks 12-chemotherapy completion)</time_frame>
    <description>Tolerability was defined for each intervention exercise training phase by the percent of weekly exercise minutes completed at the prescribed exercise intensity according to the patient's heart rate monitor.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Cardiopulmonary Fitness Level From Baseline to the Window Following Chemotherapy Completion and Before Surgical Resection</measure>
    <time_frame>Baseline and the window following chemotherapy completion and before surgical resection (no longer than 26 weeks from baseline)</time_frame>
    <description>Expired gas analysis (oxygen used by the body) during a submaximal treadmill exercise test determined cardiopulmonary fitness. Change between baseline and the window following chemotherapy completion and before surgical resection, was calculated as the value at the test conducted in the window following chemotherapy completion and before surgical resection minus the value at the test conducted at baseline.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">19</enrollment>
  <condition>Breast Neoplasm</condition>
  <condition>Physical Activity</condition>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>We ask that participants in the control arm do not start an exercise program.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Exercise</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants in the experimental arm will be asked to complete the exercise intervention with 80% or greater adherence.&#xD;
Participants will work towards the goal of 75 or more minutes a week of moderate to vigorous exercise. Participants are provided an exercise toolkit and directed on exercise progression based on personal fitness level.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Exercise</intervention_name>
    <description>All participants randomized to the intervention group will be asked to keep an exercise log with the date, time, average heart rate obtained from a heart rate monitor, duration of workout and stretching, and any comments regarding the workout. Participants will be instructed to bring workout logs to infusion sessions for review. Participants will also wear a Polar Heart Rate monitor (US model RS400, Polar Electro Inc., Lake Success, NY) during exercise to monitor exercise intensity.&#xD;
The aerobic exercise intervention will work toward the target of 75 minutes physical activity per week at 60%-85% of baseline VO2max.</description>
    <arm_group_label>Exercise</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        3.1 Inclusion Criteria&#xD;
&#xD;
          -  Women with a breast cancer diagnosis (Stage I-IIIC)&#xD;
&#xD;
          -  Sedentary (&lt; 75 min/wk of moderate intensity exercise over the past month)&#xD;
&#xD;
          -  No previous history of anthracycline based chemotherapy&#xD;
&#xD;
          -  Absence of heart disease (clinical diagnosis of coronary artery disease, arrhythmias,&#xD;
             congenital heart defects, dilated cardiomyopathy, or valvular heart disease)&#xD;
&#xD;
          -  Absence of contraindications for neoadjuvant chemotherapy&#xD;
&#xD;
          -  Scheduled to receive neoadjuvant chemotherapy&#xD;
&#xD;
          -  Primary attending oncologist approval&#xD;
&#xD;
        3.2 Exclusion Criteria&#xD;
&#xD;
          -  Absolute contraindications for exercise stress testing&#xD;
&#xD;
               -  acute myocardial infarction (3-5 days)&#xD;
&#xD;
               -  unstable angina&#xD;
&#xD;
               -  uncontrolled arrhythmias causing symptoms or hemodynamic compromise&#xD;
&#xD;
               -  syncope&#xD;
&#xD;
               -  acute endocarditis&#xD;
&#xD;
               -  acute myocarditis or pericarditis&#xD;
&#xD;
               -  uncontrolled heart failure&#xD;
&#xD;
               -  acute pulmonary embolus or pulmonary infarction&#xD;
&#xD;
               -  thrombosis of lower extremities&#xD;
&#xD;
               -  suspected dissecting aneurysm&#xD;
&#xD;
               -  uncontrolled asthma&#xD;
&#xD;
               -  pulmonary edema&#xD;
&#xD;
               -  room air desaturation at rest ≤85%&#xD;
&#xD;
               -  respiratory failure&#xD;
&#xD;
               -  acute noncardiopulmonary disorder that may affect exercise performance or be&#xD;
                  aggravated by exercise&#xD;
&#xD;
               -  mental impairment leading to inability to cooperate&#xD;
&#xD;
               -  decisional impairment&#xD;
&#xD;
          -  Non-English speaking&#xD;
&#xD;
          -  Women only diagnosed with ductal carcinoma in situ&#xD;
&#xD;
          -  Women diagnosed with stage 4 metastatic breast cancer&#xD;
&#xD;
          -  Pregnant women&#xD;
&#xD;
          -  Men&#xD;
&#xD;
          -  Children&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kathleen M Sturgeon, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Assistant Professor, Penn State</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Penn State Hershey Medical Center</name>
      <address>
        <city>Hershey</city>
        <state>Pennsylvania</state>
        <zip>17033</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Pennsylvania</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <results_reference>
    <citation>Sturgeon KM, Smith AM, Federici EH, Kodali N, Kessler R, Wyluda E, Cream LV, Ky B, Schmitz KH. Feasibility of a tailored home-based exercise intervention during neoadjuvant chemotherapy in breast cancer patients. BMC Sports Sci Med Rehabil. 2022 Feb 25;14(1):31. doi: 10.1186/s13102-022-00420-6.</citation>
    <PMID>35216638</PMID>
  </results_reference>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>August 31, 2017</study_first_submitted>
  <study_first_submitted_qc>September 11, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 13, 2017</study_first_posted>
  <results_first_submitted>March 16, 2022</results_first_submitted>
  <results_first_submitted_qc>May 25, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">May 31, 2023</results_first_posted>
  <last_update_submitted>May 25, 2023</last_update_submitted>
  <last_update_submitted_qc>May 25, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 31, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Milton S. Hershey Medical Center</investigator_affiliation>
    <investigator_full_name>Kathleen Sturgeon</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Breast Neoplasms</mesh_term>
  </condition_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>January 4, 2022</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/36/NCT03280836/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>October 21, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/36/NCT03280836/ICF_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Control</title>
          <description>We ask that participants in the control arm do not start an exercise program.</description>
        </group>
        <group group_id="P2">
          <title>Exercise</title>
          <description>Participants in the experimental arm will be asked to complete the exercise intervention with 80% or greater adherence.&#xD;
Participants will work towards the goal of 75 or more minutes a week of moderate to vigorous exercise. Participants are provided an exercise toolkit and directed on exercise progression based on personal fitness level.&#xD;
Exercise: All participants randomized to the intervention group will be asked to keep an exercise log with the date, time, average heart rate obtained from a heart rate monitor, duration of workout and stretching, and any comments regarding the workout. Participants will be instructed to bring workout logs to infusion sessions for review. Participants will also wear a Polar Heart Rate monitor (US model RS400, Polar Electro Inc., Lake Success, NY) during exercise to monitor exercise intensity.&#xD;
The aerobic exercise intervention will work toward the target of 75 minutes physical activity per week at 60%-85% of baseline VO2max.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
                <participants group_id="P2" count="9"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
                <participants group_id="P2" count="8"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Control</title>
          <description>We ask that participants in the control arm do not start an exercise program.</description>
        </group>
        <group group_id="B2">
          <title>Exercise</title>
          <description>Participants in the experimental arm will be asked to complete the exercise intervention with 80% or greater adherence.&#xD;
Participants will work towards the goal of 75 or more minutes a week of moderate to vigorous exercise. Participants are provided an exercise toolkit and directed on exercise progression based on personal fitness level.&#xD;
Exercise: All participants randomized to the intervention group will be asked to keep an exercise log with the date, time, average heart rate obtained from a heart rate monitor, duration of workout and stretching, and any comments regarding the workout. Participants will be instructed to bring workout logs to infusion sessions for review. Participants will also wear a Polar Heart Rate monitor (US model RS400, Polar Electro Inc., Lake Success, NY) during exercise to monitor exercise intensity.&#xD;
The aerobic exercise intervention will work toward the target of 75 minutes physical activity per week at 60%-85% of baseline VO2max.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="10"/>
            <count group_id="B2" value="9"/>
            <count group_id="B3" value="19"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <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="51.5" spread="9.5"/>
                    <measurement group_id="B2" value="47.0" spread="11.7"/>
                    <measurement group_id="B3" value="49.4" spread="10.5"/>
                  </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="10"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="19"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="19"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </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 group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="13"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Acceptability: Percent of Eligible Patients That Provide Consent and Are Enrolled in the Study.</title>
        <description>Acceptability of the study will be assessed by documenting the percent of eligible patients that provide consent and are enrolled in the study.</description>
        <time_frame>4 weeks</time_frame>
        <population>Female breast cancer patients (Stage I-IIIC)&#xD;
Sedentary&#xD;
No previous history of anthracycline based chemotherapy&#xD;
Absence of heart disease&#xD;
Absence of contraindications for neoadjuvant chemotherapy&#xD;
Scheduled to receive neoadjuvant chemotherapy&#xD;
Primary attending oncologist approval&#xD;
English speaking&#xD;
Absence of contraindications for exercise stress testing</population>
        <group_list>
          <group group_id="O1">
            <title>All Eligible Individuals</title>
            <description>The target population that is eligible for the study is:&#xD;
Women with a breast cancer diagnosis (Stage I-IIIC)&#xD;
Sedentary (&lt; 75 min/wk of moderate intensity exercise over the past month)&#xD;
No previous history of anthracycline based chemotherapy&#xD;
Absence of heart disease (clinical diagnosis of coronary artery disease, arrhythmias, congenital heart defects, dilated cardiomyopathy, or valvular heart disease)&#xD;
Absence of contraindications for neoadjuvant chemotherapy&#xD;
Scheduled to receive neoadjuvant chemotherapy&#xD;
Primary attending oncologist approval&#xD;
English speaking&#xD;
Absence of contraindications to exercise stress testing</description>
          </group>
        </group_list>
        <measure>
          <title>Acceptability: Percent of Eligible Patients That Provide Consent and Are Enrolled in the Study.</title>
          <description>Acceptability of the study will be assessed by documenting the percent of eligible patients that provide consent and are enrolled in the study.</description>
          <population>Female breast cancer patients (Stage I-IIIC)&#xD;
Sedentary&#xD;
No previous history of anthracycline based chemotherapy&#xD;
Absence of heart disease&#xD;
Absence of contraindications for neoadjuvant chemotherapy&#xD;
Scheduled to receive neoadjuvant chemotherapy&#xD;
Primary attending oncologist approval&#xD;
English speaking&#xD;
Absence of contraindications for exercise stress testing</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="74"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Participant Adherence to the Exercise Intervention</title>
        <description>Tolerability was defined for each intervention exercise training phase by the percent of weekly exercise minutes completed at the prescribed exercise intensity according to the patient's heart rate monitor.</description>
        <time_frame>Introduction phase of prescribed exercise training (weeks 1-4), intermediate phase of prescribed exercise training (weeks 5-11), maintenance phase of prescribed exercise training (weeks 12-chemotherapy completion)</time_frame>
        <population>The control group was not given heart rate monitors or an exercise prescription.</population>
        <group_list>
          <group group_id="O1">
            <title>Control</title>
            <description>We ask that participants in the control arm do not start an exercise program.</description>
          </group>
          <group group_id="O2">
            <title>Exercise</title>
            <description>Participants in the experimental arm will be asked to complete the exercise intervention with 80% or greater adherence.&#xD;
Participants will work towards the goal of 75 or more minutes a week of moderate to vigorous exercise. Participants are provided an exercise toolkit and directed on exercise progression based on personal fitness level.&#xD;
Exercise: All participants randomized to the intervention group will be asked to keep an exercise log with the date, time, average heart rate obtained from a heart rate monitor, duration of workout and stretching, and any comments regarding the workout. Participants will be instructed to bring workout logs to infusion sessions for review. Participants will also wear a Polar Heart Rate monitor (US model RS400, Polar Electro Inc., Lake Success, NY) during exercise to monitor exercise intensity.&#xD;
The aerobic exercise intervention will work toward the target of 75 minutes physical activity per week at 60%-85% of baseline VO2max.</description>
          </group>
        </group_list>
        <measure>
          <title>Participant Adherence to the Exercise Intervention</title>
          <description>Tolerability was defined for each intervention exercise training phase by the percent of weekly exercise minutes completed at the prescribed exercise intensity according to the patient's heart rate monitor.</description>
          <population>The control group was not given heart rate monitors or an exercise prescription.</population>
          <units>% exercise time at prescribed heart rate</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Introduction phase</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="72.7" spread="11.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Intermediate phase</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="61.0" spread="5.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Maintenance phase</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="23.7" spread="7.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change in Cardiopulmonary Fitness Level From Baseline to the Window Following Chemotherapy Completion and Before Surgical Resection</title>
        <description>Expired gas analysis (oxygen used by the body) during a submaximal treadmill exercise test determined cardiopulmonary fitness. Change between baseline and the window following chemotherapy completion and before surgical resection, was calculated as the value at the test conducted in the window following chemotherapy completion and before surgical resection minus the value at the test conducted at baseline.</description>
        <time_frame>Baseline and the window following chemotherapy completion and before surgical resection (no longer than 26 weeks from baseline)</time_frame>
        <population>Patients that withdrew, were lost to follow up, or developed treatment-induced contraindications to exercise testing, are not included in the analysis population.</population>
        <group_list>
          <group group_id="O1">
            <title>Control</title>
            <description>We ask that participants in the control arm do not start an exercise program.</description>
          </group>
          <group group_id="O2">
            <title>Exercise</title>
            <description>Participants in the experimental arm will be asked to complete the exercise intervention with 80% or greater adherence.&#xD;
Participants will work towards the goal of 75 or more minutes a week of moderate to vigorous exercise. Participants are provided an exercise toolkit and directed on exercise progression based on personal fitness level.&#xD;
Exercise: All participants randomized to the intervention group will be asked to keep an exercise log with the date, time, average heart rate obtained from a heart rate monitor, duration of workout and stretching, and any comments regarding the workout. Participants will be instructed to bring workout logs to infusion sessions for review. Participants will also wear a Polar Heart Rate monitor (US model RS400, Polar Electro Inc., Lake Success, NY) during exercise to monitor exercise intensity.&#xD;
The aerobic exercise intervention will work toward the target of 75 minutes physical activity per week at 60%-85% of baseline VO2max.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Cardiopulmonary Fitness Level From Baseline to the Window Following Chemotherapy Completion and Before Surgical Resection</title>
          <description>Expired gas analysis (oxygen used by the body) during a submaximal treadmill exercise test determined cardiopulmonary fitness. Change between baseline and the window following chemotherapy completion and before surgical resection, was calculated as the value at the test conducted in the window following chemotherapy completion and before surgical resection minus the value at the test conducted at baseline.</description>
          <population>Patients that withdrew, were lost to follow up, or developed treatment-induced contraindications to exercise testing, are not included in the analysis population.</population>
          <units>ml/kg/min</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-27.5" spread="7.4"/>
                    <measurement group_id="O2" value="-1.0" spread="13.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Approximately 9 months, from consent to final testing.</time_frame>
      <desc>Systematic review of EMR for serious adverse events, systematic use of injury history questionnaire at follow up testing. The injury history questionnaire contains self-report for all adverse events that are specific and non-specific to exercise training. The &quot;at Risk&quot; population for &quot;Other (Not Including Serious) Adverse Events&quot; is reflective of women that completed the questionnaire at follow up.</desc>
      <group_list>
        <group group_id="E1">
          <title>Control</title>
          <description>We ask that participants in the control arm do not start an exercise program.</description>
        </group>
        <group group_id="E2">
          <title>Exercise</title>
          <description>Participants in the experimental arm will be asked to complete the exercise intervention with 80% or greater adherence.&#xD;
Participants will work towards the goal of 75 or more minutes a week of moderate to vigorous exercise. Participants are provided an exercise toolkit and directed on exercise progression based on personal fitness level.&#xD;
Exercise: All participants randomized to the intervention group will be asked to keep an exercise log with the date, time, average heart rate obtained from a heart rate monitor, duration of workout and stretching, and any comments regarding the workout. Participants will be instructed to bring workout logs to infusion sessions for review. Participants will also wear a Polar Heart Rate monitor (US model RS400, Polar Electro Inc., Lake Success, NY) during exercise to monitor exercise intensity.&#xD;
The aerobic exercise intervention will work toward the target of 75 minutes physical activity per week at 60%-85% of baseline VO2max.</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Systematic Assessment</default_assessment>
        <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="10"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="10"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="9"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="9"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Chest pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Cardiac palpitations</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="9"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>cholecystitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="9"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Allergic reaction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="9"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Febrile neutropenia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="9"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Rhabdomyolysis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="9"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Neuropathy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="9"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Renal failure</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="9"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>respiratory distress</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="9"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Thrombosis/embolism</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="9"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Chest pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Joint Pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Muscle pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT 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 to recruitment at n=19, 1 patient short of anticipated enrollment (n=20) due to the COVID-19 pandemic.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Dr. Kathleen Sturgeon</name_or_title>
      <organization>Penn State University</organization>
      <phone>7175314530 ext 284676</phone>
      <email>kms99@psu.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/NCT03280836
org study id: 5517
nct id: NCT03280836
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The investigators seek to conduct a home based exercise intervention in breast cancer
      patients whom elect to undergo neoadjuvant chemotherapy. The primary aim of the study is to
      determine whether breast cancer patients can be enrolled, randomized, retained, and comply
      with exercise program; and, the feasibility of acquiring, managing and analyzing clinical
      data.
Several national and international agencies recommend exercise participation for all persons
      following a cancer diagnosis. The current evidence suggests that aerobic exercise training is
      safe during primary adjuvant therapy and improves cardiopulmonary function and patient
      related outcomes. Cardiopulmonary fitness is highly predictive of overall and cardiovascular
      specific mortality in women. Specifically, an increase in cardiopulmonary fitness of
      approximately 10% has been associated with a 19% reduction in risk for CV mortality. This is
      important as breast cancer patients already present at diagnosis with 31% lower
      cardiopulmonary fitness levels compared to healthy age-matched women. This enhanced risk for
      cardiovascular mortality in breast cancer patients is further compounded by cardiotoxic
      chemotherapy, which causes permanent cardiac damage. Few studies have tested the efficacy of
      exercise prescriptions that incorporate high intensity aerobic exercise training in cancer
      patients, especially those receiving chemotherapy. Therefore, the investigators seek to
      conduct an at home aerobic exercise training intervention in breast cancer patients whom
      elect to undergo neoadjuvant chemotherapy
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Participants are randomized to the intervention or control arm.
primary purpose: Supportive Care
masking: Double (Care Provider, Outcomes Assessor)
measure: Acceptability: Percent of Eligible Patients That Provide Consent and Are Enrolled in the Study.
time frame: 4 weeks
description: Acceptability of the study will be assessed by documenting the percent of eligible patients that provide consent and are enrolled in the study.
measure: Participant Adherence to the Exercise Intervention
time frame: Introduction phase of prescribed exercise training (weeks 1-4), intermediate phase of prescribed exercise training (weeks 5-11), maintenance phase of prescribed exercise training (weeks 12-chemotherapy completion)
description: Tolerability was defined for each intervention exercise training phase by the percent of weekly exercise minutes completed at the prescribed exercise intensity according to the patient's heart rate monitor.
measure: Change in Cardiopulmonary Fitness Level From Baseline to the Window Following Chemotherapy Completion and Before Surgical Resection
time frame: Baseline and the window following chemotherapy completion and before surgical resection (no longer than 26 weeks from baseline)
description: Expired gas analysis (oxygen used by the body) during a submaximal treadmill exercise test determined cardiopulmonary fitness. Change between baseline and the window following chemotherapy completion and before surgical resection, was calculated as the value at the test conducted in the window following chemotherapy completion and before surgical resection minus the value at the test conducted at baseline.
arm group label: Control
arm group type: No Intervention
description: We ask that participants in the control arm do not start an exercise program.
arm group label: Exercise
arm group type: Experimental
description: Participants in the experimental arm will be asked to complete the exercise intervention with 80% or greater adherence.
Participants will work towards the goal of 75 or more minutes a week of moderate to vigorous exercise. Participants are provided an exercise toolkit and directed on exercise progression based on personal fitness level.
intervention type: Behavioral
intervention name: Exercise
description: All participants randomized to the intervention group will be asked to keep an exercise log with the date, time, average heart rate obtained from a heart rate monitor, duration of workout and stretching, and any comments regarding the workout. Participants will be instructed to bring workout logs to infusion sessions for review. Participants will also wear a Polar Heart Rate monitor (US model RS400, Polar Electro Inc., Lake Success, NY) during exercise to monitor exercise intensity.
The aerobic exercise intervention will work toward the target of 75 minutes physical activity per week at 60%-85% of baseline VO2max.
arm group label: Exercise
criteria: 
gender: Female
minimum age: 21 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Kathleen M Sturgeon, PhD
role: Principal Investigator
affiliation: Assistant Professor, Penn State
facility: 
facility: 
country: United States
citation: Sturgeon KM, Smith AM, Federici EH, Kodali N, Kessler R, Wyluda E, Cream LV, Ky B, Schmitz KH. Feasibility of a tailored home-based exercise intervention during neoadjuvant chemotherapy in breast cancer patients. BMC Sports Sci Med Rehabil. 2022 Feb 25;14(1):31. doi: 10.1186/s13102-022-00420-6.
PMID: 35216638
responsible party type: Principal Investigator
investigator affiliation: Milton S. Hershey Medical Center
investigator full name: Kathleen Sturgeon
investigator title: Assistant Professor
mesh term: Breast Neoplasms
sharing ipd: No
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: The study was closed to recruitment at n=19, 1 patient short of anticipated enrollment (n=20) due to the COVID-19 pandemic.
point of contact: 