<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/NCT04449809</url>
  </required_header>
  <id_info>
    <org_study_id>Pro00104863</org_study_id>
    <nct_id>NCT04449809</nct_id>
  </id_info>
  <brief_title>Exercise Regimen Designed to Improve Functional Mobility, Body Composition, and Strength After Breast Conservation Therapy for Women With Early Stage Breast Cancer</brief_title>
  <acronym>EXERT-BC</acronym>
  <official_title>Pilot Study of the Feasibility of an Exercise Regimen Designed to Improve Functional Mobility, Body Composition, and Strength After Breast Conservation Therapy for Women With Early Stage Breast Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Duke University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Duke University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this research study is to find out if a monitored group exercise program can&#xD;
      increase strength, muscle mass and ability to move in women after treatment for early stage&#xD;
      breast cancer.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This trial will assess the safety and feasibility of a monitored group exercise regimen&#xD;
      utilizing high-load resistance training and functional exercises with compound movements in a&#xD;
      group of women treated for early stage breast cancer with the goal of improving functional&#xD;
      mobility, body composition, and strength after breast conservation therapy.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Unable to enroll due to COVID-19&#xD;
  </why_stopped>
  <start_date type="Anticipated">September 2021</start_date>
  <completion_date type="Anticipated">September 2022</completion_date>
  <primary_completion_date type="Anticipated">September 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Adherence, defined as the proportion of participants completing at least 75% of the planned exercise sessions</measure>
    <time_frame>12 weeks</time_frame>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Breast Cancer</condition>
  <arm_group>
    <arm_group_label>Exercise</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Exercise program</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Exercise program</intervention_name>
    <description>3x per week group monitored group exercise sessions</description>
    <arm_group_label>Exercise</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age 30-70 years&#xD;
&#xD;
          2. Women with a biopsy proven diagnosis of ductal carcinoma in situ or invasive carcinoma&#xD;
             of the breast&#xD;
&#xD;
          3. Women must have undergone breast conservation therapy with no neoadjuvant or adjuvant&#xD;
             chemotherapy (adjuvant endocrine therapy is permitted)&#xD;
&#xD;
          4. BMI &gt; 25 kg/m2 or body fat% greater or equal to 31%&#xD;
&#xD;
          5. Participants must have abstained from smoking for at least 12 months&#xD;
&#xD;
          6. Women of child-bearing potential must verbally confirm lack of pregnancy prior to&#xD;
             enrollment and have undergone a pregnancy test prior to initial of radiation therapy&#xD;
             (standard protocol for radiation therapy). They should also consent to use adequate&#xD;
             contraception during the course of the study.&#xD;
&#xD;
          7. Women must be determined capable of engaging in resistance training as documented in&#xD;
             treating radiation oncologist notes.&#xD;
&#xD;
          8. Participants must have a schedule amenable to three prescheduled workout sessions per&#xD;
             week, scheduled during the day.&#xD;
&#xD;
          9. Women must complete a Functional Mobility Screen (FMS) and determined safe to engage&#xD;
             in the workout regimen by the study personnel.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Any treatment with chemotherapy for recent breast cancer treatment&#xD;
&#xD;
          2. Mastectomy and/or lymph node dissection&#xD;
&#xD;
          3. Uncontrolled hypertension or diabetes, defined as systolic blood pressure over 149,&#xD;
             diastolic blood pressure over 99, and hemoglobin A1c greater than 8.9.&#xD;
&#xD;
          4. Diabetic condition requiring the usage of insulin&#xD;
&#xD;
          5. Severe arthritic, joint, cardiovascular, or musculoskeletal condition&#xD;
&#xD;
          6. Inability to perform body weight squat exercise without pain assessed by treating&#xD;
             radiation oncologist&#xD;
&#xD;
          7. History of myocardial infarction or coronary artery disease&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Colin Champ, MD CSCS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Duke University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Duke Cancer 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>
  <verification_date>June 2021</verification_date>
  <study_first_submitted>June 24, 2020</study_first_submitted>
  <study_first_submitted_qc>June 24, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 29, 2020</study_first_posted>
  <last_update_submitted>June 15, 2021</last_update_submitted>
  <last_update_submitted_qc>June 15, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">June 21, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>exercise</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>No</sharing_ipd>
  </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/NCT04449809
org study id: Pro00104863
nct id: NCT04449809
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this research study is to find out if a monitored group exercise program can
      increase strength, muscle mass and ability to move in women after treatment for early stage
      breast cancer.
This trial will assess the safety and feasibility of a monitored group exercise regimen
      utilizing high-load resistance training and functional exercises with compound movements in a
      group of women treated for early stage breast cancer with the goal of improving functional
      mobility, body composition, and strength after breast conservation therapy.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Adherence, defined as the proportion of participants completing at least 75% of the planned exercise sessions
time frame: 12 weeks
arm group label: Exercise
arm group type: Experimental
description: Exercise program
intervention type: Behavioral
intervention name: Exercise program
description: 3x per week group monitored group exercise sessions
arm group label: Exercise
criteria: 
gender: Female
minimum age: 30 Years
maximum age: 70 Years
healthy volunteers: No
last name: Colin Champ, MD CSCS
role: Principal Investigator
affiliation: Duke University
facility: 
country: United States
responsible party type: Sponsor
mesh term: Breast Neoplasms
sharing ipd: No