<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/NCT04458532</url>
  </required_header>
  <id_info>
    <org_study_id>20-130</org_study_id>
    <nct_id>NCT04458532</nct_id>
  </id_info>
  <brief_title>Exercise Therapy to Improve Cardiovascular Health in Post-Menopausal Women After Treatment for Early Stage Breast Cancer</brief_title>
  <official_title>A Randomized Trial to Minimize Non-Response to Aerobic Training in Post-Menopausal Women With Early Stage Breast Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Memorial Sloan Kettering Cancer Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </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>
      This study will compare the effects on cardiorespiratory fitness (CRF) of aerobic exercise in&#xD;
      different amounts (number of minutes/session) over different periods of time (number of&#xD;
      weeks). Aerobic exercise is physical activity of light-to-moderate intensity that uses the&#xD;
      large muscle groups (muscles in your legs, buttocks, back, and chest) and can be performed&#xD;
      for at least 10 minutes.&#xD;
&#xD;
      The researchers will study the effects of different exercise programs on how well the study&#xD;
      participants' bodies use oxygen, how well their heart pumps blood, how well their lungs&#xD;
      function, and how healthy their blood vessels are.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Prior to the initiation of every supervised aerobic training session, patient resting vital&#xD;
      signs will be assessed to ensure the patient can safely proceed with the session. Vital&#xD;
      signs, including resting heart rate and blood pressure, will be collected and monitored per&#xD;
      ExOnc program guidelines. In addition, the planned session will not be initiated if the ExOnc&#xD;
      staff member observes any concerns that may compromise participant safety and/or the&#xD;
      integrity of the planned session. Vital sign monitoring guidelines for unsupervised sessions,&#xD;
      prescribed at lower intensities, will be advised by the exercise physiologist at the time the&#xD;
      session plan is provided to the patient. Patients will be instructed to not begin an&#xD;
      unsupervised session if their resting heart rate or blood pressure is outside the recommended&#xD;
      guidelines.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">October 8, 2020</start_date>
  <completion_date type="Anticipated">July 2025</completion_date>
  <primary_completion_date type="Anticipated">July 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>This is a single-center randomized controlled trial (RCT) study designed to evaluate the cardiorespiratory fitness (CRF) response rate to different aerobic therapy (AT) doses in patients with post-treatment primary breast cancer.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>peak oxygen consumption (VO2peak; ml O2.kg-1.min) response rate</measure>
    <time_frame>32 weeks</time_frame>
    <description>A CRF change ≥1.32 ml O2.kg-1.min-1 will be considered a response; a change &lt;1.32 ml O2.kg-1.min-1 will be considered a non-response.</description>
  </primary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Anticipated">152</enrollment>
  <condition>Early Stage Breast Cancer</condition>
  <arm_group>
    <arm_group_label>(A) breast cancer after completion of chemo</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>300 min/wk for 16 weeks, followed by 16 weeks of usual care.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>(B) breast cancer after completion of chemo</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>150 min/wk for 32 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>(C) breast cancer after completion of chemo</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>300 min/wk for 32 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>(D) breast cancer after completion of chemo</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>150 min/wk for 16 weeks, followed by 16 weeks of usual care.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Aerobic Training</intervention_name>
    <description>300 min/wk for 16 weeks</description>
    <arm_group_label>(A) breast cancer after completion of chemo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Aerobic Training</intervention_name>
    <description>150 min/wk for 32 weeks</description>
    <arm_group_label>(B) breast cancer after completion of chemo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Aerobic Training</intervention_name>
    <description>300 min/wk for 32 weeks</description>
    <arm_group_label>(C) breast cancer after completion of chemo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Aerobic Training</intervention_name>
    <description>150 min/wk for 16 weeks</description>
    <arm_group_label>(D) breast cancer after completion of chemo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Aged 21-80 years&#xD;
&#xD;
          -  Female&#xD;
&#xD;
          -  Surgically resected early stage (I-III) primary breast cancer&#xD;
&#xD;
          -  Post-menopausal, defined as one of the following:&#xD;
&#xD;
               -  Age ≥ 45 with no menses for at least 2 years&#xD;
&#xD;
               -  Chemically and/or surgically induced menopause through ovarian suppression, as&#xD;
                  determined by the primary oncologist&#xD;
&#xD;
               -  Estradiol level of ≤30 pg/mL&#xD;
&#xD;
          -  An interval of at least one year, but no more than five years, following the full&#xD;
             completion of definitive therapy for malignant disease. Definitive therapy is defined&#xD;
             as:&#xD;
&#xD;
               -  Surgery plus radiation&#xD;
&#xD;
               -  Surgery plus chemotherapy&#xD;
&#xD;
               -  Surgery plus trastuzumab&#xD;
&#xD;
          -  Exercise intolerance (i.e., patients must have a VO2peak below the predicted for&#xD;
             active age and sex-matched individuals. (+/- the technical error of 1.32 mL/kg/min)].&#xD;
&#xD;
        Note: Normative values are available up to 80 years of age)&#xD;
&#xD;
          -  Able to complete an acceptable baseline CPET, in the absence of high-risk ECG findings&#xD;
             or other inappropriate response to exercise as determined by the PI, as defined by any&#xD;
             of the following criteria:&#xD;
&#xD;
               -  Achieving a plateau in oxygen consumption, concurrent with an increase in power&#xD;
                  output;&#xD;
&#xD;
               -  A respiratory exchange ratio ≥ 1.10;&#xD;
&#xD;
               -  Attainment of maximal predicted heart rate (HRmax) (i.e., within 10 bpm of&#xD;
                  age-predicted HRmax [HRmax = 220-Age[years]);&#xD;
&#xD;
               -  Volitional exhaustion, as measured by a rating of perceived exertion (RPE) ≥ 18&#xD;
                  on the BORG scale&#xD;
&#xD;
          -  Willingness to comply with all study-related procedures.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any of the following absolute contraindications to cardiopulmonary exercise testing:&#xD;
&#xD;
               -  Acute myocardial infarction within 3-5 days of any planned study procedures&#xD;
&#xD;
               -  Unstable angina&#xD;
&#xD;
               -  Uncontrolled arrhythmia causing symptoms or hemodynamic compromise&#xD;
&#xD;
               -  Recurrent syncope&#xD;
&#xD;
               -  Active endocarditis&#xD;
&#xD;
               -  Acute myocarditis or pericarditis&#xD;
&#xD;
               -  Symptomatic severe aortic stenosis&#xD;
&#xD;
               -  Uncontrolled heart failure&#xD;
&#xD;
               -  Acute pulmonary embolus or pulmonary infarction within 3 months of any planned&#xD;
                  study procedures&#xD;
&#xD;
               -  Thrombosis of lower extremities&#xD;
&#xD;
               -  Suspected dissecting aneurysm&#xD;
&#xD;
               -  Uncontrolled asthma&#xD;
&#xD;
               -  Pulmonary edema&#xD;
&#xD;
               -  Respiratory failure&#xD;
&#xD;
               -  Acute non-cardiopulmonary disorders that may affect exercise performance or be&#xD;
                  aggravated by exercise (e.g., infection, renal failure, thyrotoxicosis)&#xD;
&#xD;
          -  Presence of any other concurrent, actively treated malignancy&#xD;
&#xD;
          -  History of any other malignancy treated within the past 3 years (other than&#xD;
             non-melanoma skin cancer)&#xD;
&#xD;
          -  Presence of distant metastatic disease (i.e., stage IV)&#xD;
&#xD;
          -  Room air desaturation at rest ≤ 85%&#xD;
&#xD;
          -  Mental impairment leading to inability to cooperate.&#xD;
&#xD;
          -  Any other condition or intercurrent illness that, in the opinion of the investigator,&#xD;
             makes the participant a poor candidate for the trial.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Post-Menopausal Women After Treatment for Early Stage Breast Cancer</gender_description>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jessica Scott, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Memorial Sloan Kettering Cancer Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jessica Scott, PhD</last_name>
    <phone>646-888-8103</phone>
    <email>scottj1@mskcc.org</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Lee Jones, PhD</last_name>
    <phone>646-888-8103</phone>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Hartford Healthcare Cancer Institute @ Hartford Hospital (Data Collection Only)</name>
      <address>
        <city>Hartford</city>
        <state>Connecticut</state>
        <zip>06102</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Andrew Salner, MD</last_name>
      <phone>860-972-2803</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>Jessica Scott, PhD</last_name>
      <phone>646-888-8103</phone>
    </contact>
    <contact_backup>
      <last_name>Lee Jones, PhD</last_name>
      <phone>646-888-8103</phone>
    </contact_backup>
    <investigator>
      <last_name>Jessica Scott, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </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>July 2023</verification_date>
  <study_first_submitted>July 2, 2020</study_first_submitted>
  <study_first_submitted_qc>July 2, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 7, 2020</study_first_posted>
  <last_update_submitted>July 31, 2023</last_update_submitted>
  <last_update_submitted_qc>July 31, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 1, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Exercise Therapy</keyword>
  <keyword>Aerobic Training</keyword>
  <keyword>Post-Menopausal Women</keyword>
  <keyword>20-130</keyword>
  <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>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 beginning 12 months after publication and for up to 36 months post publication. 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>
  </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/NCT04458532
org study id: 20-130
nct id: NCT04458532
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
This study will compare the effects on cardiorespiratory fitness (CRF) of aerobic exercise in
      different amounts (number of minutes/session) over different periods of time (number of
      weeks). Aerobic exercise is physical activity of light-to-moderate intensity that uses the
      large muscle groups (muscles in your legs, buttocks, back, and chest) and can be performed
      for at least 10 minutes.

      The researchers will study the effects of different exercise programs on how well the study
      participants' bodies use oxygen, how well their heart pumps blood, how well their lungs
      function, and how healthy their blood vessels are.
Prior to the initiation of every supervised aerobic training session, patient resting vital
      signs will be assessed to ensure the patient can safely proceed with the session. Vital
      signs, including resting heart rate and blood pressure, will be collected and monitored per
      ExOnc program guidelines. In addition, the planned session will not be initiated if the ExOnc
      staff member observes any concerns that may compromise participant safety and/or the
      integrity of the planned session. Vital sign monitoring guidelines for unsupervised sessions,
      prescribed at lower intensities, will be advised by the exercise physiologist at the time the
      session plan is provided to the patient. Patients will be instructed to not begin an
      unsupervised session if their resting heart rate or blood pressure is outside the recommended
      guidelines.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: This is a single-center randomized controlled trial (RCT) study designed to evaluate the cardiorespiratory fitness (CRF) response rate to different aerobic therapy (AT) doses in patients with post-treatment primary breast cancer.
primary purpose: Treatment
masking: None (Open Label)
measure: peak oxygen consumption (VO2peak; ml O2.kg-1.min) response rate
time frame: 32 weeks
description: A CRF change ≥1.32 ml O2.kg-1.min-1 will be considered a response; a change <1.32 ml O2.kg-1.min-1 will be considered a non-response.
arm group label: (A) breast cancer after completion of chemo
arm group type: Experimental
description: 300 min/wk for 16 weeks, followed by 16 weeks of usual care.
arm group label: (B) breast cancer after completion of chemo
arm group type: Experimental
description: 150 min/wk for 32 weeks.
arm group label: (C) breast cancer after completion of chemo
arm group type: Experimental
description: 300 min/wk for 32 weeks.
arm group label: (D) breast cancer after completion of chemo
arm group type: Active Comparator
description: 150 min/wk for 16 weeks, followed by 16 weeks of usual care.
intervention type: Other
intervention name: Aerobic Training
description: 300 min/wk for 16 weeks
arm group label: (A) breast cancer after completion of chemo
intervention type: Other
intervention name: Aerobic Training
description: 150 min/wk for 32 weeks
arm group label: (B) breast cancer after completion of chemo
intervention type: Other
intervention name: Aerobic Training
description: 300 min/wk for 32 weeks
arm group label: (C) breast cancer after completion of chemo
intervention type: Other
intervention name: Aerobic Training
description: 150 min/wk for 16 weeks
arm group label: (D) breast cancer after completion of chemo
criteria: 
gender: Female
gender based: Yes
gender description: Post-Menopausal Women After Treatment for Early Stage Breast Cancer
minimum age: 21 Years
maximum age: 80 Years
healthy volunteers: No
last name: Jessica Scott, PhD
role: Principal Investigator
affiliation: Memorial Sloan Kettering Cancer Center
last name: Jessica Scott, PhD
phone: 646-888-8103
email: scottj1@mskcc.org
last name: Lee Jones, PhD
phone: 646-888-8103
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: United States
url: http://www.mskcc.org/mskcc/html/44.cfm
description: Memorial Sloan Kettering Cancer Center
responsible party type: Sponsor
mesh term: Breast 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 beginning 12 months after publication and for up to 36 months post publication. 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.