<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/NCT01725633</url>
  </required_header>
  <id_info>
    <org_study_id>MSKCC 14-170</org_study_id>
    <nct_id>NCT01725633</nct_id>
    <nct_alias>NCT02239848</nct_alias>
  </id_info>
  <brief_title>Aerobic Training in Metastatic Breast Cancer</brief_title>
  <acronym>Breast Mets</acronym>
  <official_title>Phase II Trial of Aerobic Training in Metastatic Breast Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Memorial Sloan Kettering Cancer Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Duke University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Memorial Sloan Kettering Cancer Center</source>
  <brief_summary>
    <textblock>
      This study is being done to examine the safety and feasibility of a supervised progressive&#xD;
      exercise program in women diagnosed with metastatic breast cancer. Previous research among&#xD;
      women with metastatic breast cancer has shown that some of the treatments commonly used in&#xD;
      this population may have an adverse impact on physical fitness levels leading to feelings of&#xD;
      fatigue and poor quality of life. Supervised exercise training has been shown to reduce some&#xD;
      of these side-effects in women with early-stage breast cancer receiving common cancer&#xD;
      treatments. However, it is not known if supervised exercise training is a safe and feasible&#xD;
      intervention in women with metastatic breast cancer. This study is designed to find out if&#xD;
      supervised exercise training is safe as the patients undergo treatments for metastatic breast&#xD;
      cancer.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>December 2010</start_date>
  <completion_date type="Actual">April 4, 2023</completion_date>
  <primary_completion_date type="Actual">April 4, 2023</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>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>safety of aerobic training</measure>
    <time_frame>2 years</time_frame>
    <description>Safety will be evaluated by the type and prevalence of adverse events during study-related assessments as well as aerobic training and progressive stretching sessions. The NCI Common Terminology Criteria for Adverse Events Version 4.0 (NCI-CTCAE) will be used to grade toxicities during the trial.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>feasibility of aerobic training</measure>
    <time_frame>2 years</time_frame>
    <description>feasibility will be evaluated by examining several different end points including rates of study eligibility and accrual, etc; however, sample size calculations are based on an integration of aerobic training attendance rate (in the aerobic training group) as well as global trial attrition rates. Together, these end points will be used to determine overall study feasibility.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">27</enrollment>
  <condition>Metastatic Breast Cancer</condition>
  <arm_group>
    <arm_group_label>Progressive Stretching Group</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Nonlinear Aerobic Training</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Progressive Stretching Group</intervention_name>
    <description>Participants assigned to the progressive stretching group will be provided with a progressive stretching program that matches the aerobic training interventions in terms of program length (16 weeks), social interaction (all sessions will be supervised), and session duration (20-45 minutes/session, ± 10 minutes).</description>
    <arm_group_label>Progressive Stretching Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Nonlinear Aerobic Training</intervention_name>
    <description>Participants assigned to the nonlinear aerobic training arm will perform no more than 150 minutes per week of structured supervised aerobic training as part of clinical trial participation. Exercise performed outside the structured sessions (i.e., contamination) will be assessed via self-report of exercise behavior using the Godin-Leisure Time Exercise Questionnaire (GLTEQ). For ethical reasons, we will not instruct participants not to exercise outside the structured sessions, but we we will encourage participants to maintain their level of exercise behavior prior to study initiation.</description>
    <arm_group_label>Nonlinear Aerobic Training</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Blood draw</intervention_name>
    <description>At Weeks 4, and 8, all participants will have a complete blood count (CBC) test performed.</description>
    <arm_group_label>Nonlinear Aerobic Training</arm_group_label>
    <arm_group_label>Progressive Stretching Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Cardiopulmonary Exercise Testing (CPET)</intervention_name>
    <description>At the end of Week 6, participants repeat the CPET in the nonlinear aerobic training group.</description>
    <arm_group_label>Nonlinear Aerobic Training</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  MSK histologically confirmed metastatic breast cancer&#xD;
&#xD;
          -  Measurable disease (or nonmeasurable bone-only disease) assessed by CT or PET/CT&#xD;
             performed as part of standard of care, at the discretion of the attending oncologist&#xD;
             in the Breast Medicine Service&#xD;
&#xD;
          -  ≥18 years of age;&#xD;
&#xD;
          -  Life expectancy &gt;3 months;&#xD;
&#xD;
          -  ECOG ≤ 1&#xD;
&#xD;
          -  Sedentary, as per the leisure score index (LSI) of the Godin Leisure-Time Exercise&#xD;
             Questionnaire (GLTEQ) . Participants who perform regular moderate or vigorous&#xD;
             intensity exercise at least 5 days/week, for at least 30 minutes/session, are not&#xD;
             eligible&#xD;
&#xD;
          -  Able to achieve an acceptable peak baseline CPET, as defined by any of the following&#xD;
             criteria:&#xD;
&#xD;
               1. Achieving a plateau in oxygen consumption, concurrent with an increase in power&#xD;
                  output;&#xD;
&#xD;
               2. A respiratory exchange ratio ≥ 1.10;&#xD;
&#xD;
               3. Attainment of maximal predicted heart rate (HRmax) (i.e., within 10 bpm of&#xD;
                  age-predicted HRmax [HRmax = 220-Age[years]);&#xD;
&#xD;
               4. Volitional exhaustion, as measured by a rating of perceived exertion (RPE) ≥ 18&#xD;
                  on the BORG scale&#xD;
&#xD;
          -  Normal cardiac function (left ventricular ejection fraction ≥50%);&#xD;
&#xD;
          -  Medical clearance from attending oncologist indicating no relative contraindications&#xD;
             to undergo a symptom-limited cardiopulmonary exercise test and aerobic training&#xD;
             intervention;&#xD;
&#xD;
          -  Patients with &quot;treated and stable&quot; brain lesions of a duration of ≥ 2 months may be&#xD;
             enrolled&#xD;
&#xD;
          -  Willing to be randomized to one of the study arms&#xD;
&#xD;
          -  Female&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any of the following absolute contraindications to cardiopulmonary exercise testing:&#xD;
&#xD;
               1. Acute myocardial infarction within 3-5 days of any planned study procedures&#xD;
&#xD;
               2. Unstable angina&#xD;
&#xD;
               3. Uncontrolled arrhythmia causing symptoms or hemodynamic compromise;&#xD;
&#xD;
               4. Recurrent syncope&#xD;
&#xD;
               5. Active endocarditis;&#xD;
&#xD;
               6. Acute myocarditis or pericarditis&#xD;
&#xD;
               7. Symptomatic severe aortic stenosis&#xD;
&#xD;
               8. Uncontrolled heart failure&#xD;
&#xD;
               9. Acute pulmonary embolus or pulmonary infarction within 3 months of any planned&#xD;
                  study procedures&#xD;
&#xD;
              10. Thrombosis of lower extremities&#xD;
&#xD;
              11. Suspected dissecting aneurysm&#xD;
&#xD;
              12. Uncontrolled asthma&#xD;
&#xD;
              13. Pulmonary edema&#xD;
&#xD;
              14. Room air desaturation at rest ≤ 85%&#xD;
&#xD;
              15. Respiratory failure&#xD;
&#xD;
              16. Acute non-cardiopulmonary disorders that may affect exercise performance or be&#xD;
                  aggravated by exercise (i.e., infection, renal failure, thyrotoxicosis)&#xD;
&#xD;
              17. 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;
&#xD;
          -  Presence of extensive skeletal metastases, defined as more than five (5) sites of bony&#xD;
             disease, or any symptomatic site of disease in the spine, hip, or femur. Note that,&#xD;
             patients with more than five bony sites may be deemed eligible at the discretion of&#xD;
             the attending oncologist.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lee Jones, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Memorial Sloan Kettering Cancer Center</affiliation>
  </overall_official>
  <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>
  </location>
  <location>
    <facility>
      <name>Duke University Medical Center</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27710</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.mskcc.org/</url>
    <description>Memorial Sloan Kettering Cancer Center</description>
  </link>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>July 28, 2011</study_first_submitted>
  <study_first_submitted_qc>November 8, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 14, 2012</study_first_posted>
  <last_update_submitted>April 4, 2023</last_update_submitted>
  <last_update_submitted_qc>April 4, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 6, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Stretching</keyword>
  <keyword>Nonlinear Aerobic Training</keyword>
  <keyword>14-170</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Breast Neoplasms</mesh_term>
  </condition_browse>
  <!-- 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/NCT01725633
org study id: MSKCC 14-170
nct id: NCT01725633
nct alias: NCT02239848
lead sponsor: 
collaborator: 
This study is being done to examine the safety and feasibility of a supervised progressive
      exercise program in women diagnosed with metastatic breast cancer. Previous research among
      women with metastatic breast cancer has shown that some of the treatments commonly used in
      this population may have an adverse impact on physical fitness levels leading to feelings of
      fatigue and poor quality of life. Supervised exercise training has been shown to reduce some
      of these side-effects in women with early-stage breast cancer receiving common cancer
      treatments. However, it is not known if supervised exercise training is a safe and feasible
      intervention in women with metastatic breast cancer. This study is designed to find out if
      supervised exercise training is safe as the patients undergo treatments for metastatic breast
      cancer.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: safety of aerobic training
time frame: 2 years
description: Safety will be evaluated by the type and prevalence of adverse events during study-related assessments as well as aerobic training and progressive stretching sessions. The NCI Common Terminology Criteria for Adverse Events Version 4.0 (NCI-CTCAE) will be used to grade toxicities during the trial.
measure: feasibility of aerobic training
time frame: 2 years
description: feasibility will be evaluated by examining several different end points including rates of study eligibility and accrual, etc; however, sample size calculations are based on an integration of aerobic training attendance rate (in the aerobic training group) as well as global trial attrition rates. Together, these end points will be used to determine overall study feasibility.
arm group label: Progressive Stretching Group
arm group type: Other
arm group label: Nonlinear Aerobic Training
arm group type: Experimental
intervention type: Behavioral
intervention name: Progressive Stretching Group
description: Participants assigned to the progressive stretching group will be provided with a progressive stretching program that matches the aerobic training interventions in terms of program length (16 weeks), social interaction (all sessions will be supervised), and session duration (20-45 minutes/session, ± 10 minutes).
arm group label: Progressive Stretching Group
intervention type: Behavioral
intervention name: Nonlinear Aerobic Training
description: Participants assigned to the nonlinear aerobic training arm will perform no more than 150 minutes per week of structured supervised aerobic training as part of clinical trial participation. Exercise performed outside the structured sessions (i.e., contamination) will be assessed via self-report of exercise behavior using the Godin-Leisure Time Exercise Questionnaire (GLTEQ). For ethical reasons, we will not instruct participants not to exercise outside the structured sessions, but we we will encourage participants to maintain their level of exercise behavior prior to study initiation.
arm group label: Nonlinear Aerobic Training
intervention type: Other
intervention name: Blood draw
description: At Weeks 4, and 8, all participants will have a complete blood count (CBC) test performed.
arm group label: Nonlinear Aerobic Training
arm group label: Progressive Stretching Group
intervention type: Other
intervention name: Cardiopulmonary Exercise Testing (CPET)
description: At the end of Week 6, participants repeat the CPET in the nonlinear aerobic training group.
arm group label: Nonlinear Aerobic Training
criteria: 
gender: Female
minimum age: 21 Years
maximum age: N/A
healthy volunteers: No
last name: Lee Jones, PhD
role: Principal Investigator
affiliation: Memorial Sloan Kettering Cancer Center
facility: 
facility: 
country: United States
url: http://www.mskcc.org/
description: Memorial Sloan Kettering Cancer Center
responsible party type: Sponsor
mesh term: Breast Neoplasms