<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/NCT03779867</url>
  </required_header>
  <id_info>
    <org_study_id>RG1003977</org_study_id>
    <secondary_id>NCI-2018-02831</secondary_id>
    <secondary_id>8766</secondary_id>
    <nct_id>NCT03779867</nct_id>
  </id_info>
  <brief_title>Acute Exercise Intervention in Reducing Breast Cancer Risk in Healthy Participants and Breast Cancer Survivors</brief_title>
  <acronym>ACE</acronym>
  <official_title>Acute Effects of Exercise in Women (ACE) Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fred Hutchinson Cancer Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Breast Cancer Research Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Fred Hutchinson Cancer Center</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>
      This trial studies how a 45-minute bout of acute exercise in healthy women as well as women&#xD;
      with a history of breast cancer can affect factors associated with breast cancer and help&#xD;
      doctors learn more about how exercise can help prevent breast cancer.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      OUTLINE: Participants are randomized to 1 of 2 arms.&#xD;
&#xD;
      ARM I: Participants undergo a moderate-intensity acute exercise bout over 45 minutes.&#xD;
&#xD;
      ARM II: Participants rest by sitting for 45 minutes.&#xD;
&#xD;
      EXTENSION: After completion of initial study recruitment and data collection, an extension&#xD;
      was approved in 2023.&#xD;
&#xD;
      EXTENSION OUTLINE: Participants are randomized to 1 of 2 arms.&#xD;
&#xD;
      EXTENSION ARM I: Participants exercise on a stationary bike for 45 minutes.&#xD;
&#xD;
      EXTENSION ARM II: Participants rest by sitting for 45 minutes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">March 25, 2019</start_date>
  <completion_date type="Anticipated">December 31, 2024</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2024</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>Prevention</primary_purpose>
    <masking>Double (Investigator, Outcomes Assessor)</masking>
    <masking_description>All study personnel other than the statisticians and exercise physiologist will be masked to participant study arm</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Mean change in homeostatic model assessment of insulin resistance (HOMA-IR)</measure>
    <time_frame>Baseline up to 45 minutes</time_frame>
    <description>Will compare the average changes in HOMA-IR from baseline to 45 minutes between the exercisers and controls.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mean change in HOMA-IR</measure>
    <time_frame>Baseline up to 105 minutes</time_frame>
    <description>Will compare the average changes in HOMA-IR from baseline to 105 minutes between the exercisers and controls.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in insulin level</measure>
    <time_frame>Baseline up to 45 minutes</time_frame>
    <description>Will compare changes in insulin level from baseline to 45 minutes between the exercisers and controls.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in insulin level</measure>
    <time_frame>Baseline up to 105 minutes</time_frame>
    <description>Will compare changes in insulin level from baseline to 105 minutes between the exercisers and controls.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in glucose level</measure>
    <time_frame>Baseline up to 45 minutes</time_frame>
    <description>Will compare changes in glucose level from baseline to 45 minutes between the exercisers and controls.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in glucose level</measure>
    <time_frame>Baseline up to 105 minutes</time_frame>
    <description>Will compare changes in glucose level from baseline to 105 minutes between the exercisers and controls.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Vascular Endothelial Growth Factor (VEGF) level</measure>
    <time_frame>Baseline up to 45 minutes</time_frame>
    <description>Will compare changes in VEGF level from baseline to 45 minutes between the exercisers and controls.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in VEGF level</measure>
    <time_frame>Baseline up to 105 minutes</time_frame>
    <description>Will compare changes in VEGF level from baseline to 105 minutes between the exercisers and controls.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Irisin level</measure>
    <time_frame>Baseline up to 45 minutes</time_frame>
    <description>Will compare changes in Irisin level from baseline to 45 minutes between the exercisers and controls.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Irisin level</measure>
    <time_frame>Baseline up to 105 minutes</time_frame>
    <description>Will compare changes in Irisin level from baseline to 105 minutes between the exercisers and controls.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Plasminogen activator inhibitor type-1 (PAI-1) level</measure>
    <time_frame>Baseline up to 45 minutes</time_frame>
    <description>Will compare changes in PAI-1 level from baseline to 45 minutes between the exercisers and controls.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in PAI-1 level</measure>
    <time_frame>Baseline up to 105 minutes</time_frame>
    <description>Will compare changes in PAI-1 level from baseline to 105 minutes between the exercisers and controls.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Effects of exercise on HOMA-IR in normal-weight participants</measure>
    <time_frame>At 45 minutes</time_frame>
    <description>Will use the generalized estimating equations (GEE) model including the potential effect modification of weight category (normal weight versus [vs] overweight/obese) to compare the 45-minute exercise session on HOMA-IR in normal-weight versus overweight/obese women.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Effects of exercise on HOMA-IR in overweight/obese participants</measure>
    <time_frame>At 45 minutes</time_frame>
    <description>Will use the GEE model including the potential effect modification of weight category (normal weight versus [vs.] overweight/obese) to compare the 45-minute exercise session on HOMA-IR in normal-weight versus overweight/obese women.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in C-reactive protein (CRP)</measure>
    <time_frame>Baseline up to 105 minutes</time_frame>
    <description>Will compare changes in CRP level from baseline to 105 minutes between the exercisers and controls.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Interleukin (IL)-6</measure>
    <time_frame>Baseline up to 105 minutes</time_frame>
    <description>Will compare changes in IL-6 level from baseline to 105 minutes between the exercisers and controls.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Monocyte chemotactic protein (MCP)-1</measure>
    <time_frame>Baseline up to 105 minutes</time_frame>
    <description>Will compare changes in MCP-1 level from baseline to 105 minutes between the exercisers and controls.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">122</enrollment>
  <condition>Breast Carcinoma</condition>
  <arm_group>
    <arm_group_label>Arm I (acute exercise)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants undergo a moderate-intensity acute exercise bout over 45 minutes.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm II (rest)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants rest by sitting for 45 minutes.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Exercise Intervention</intervention_name>
    <description>Undergo acute exercise</description>
    <arm_group_label>Arm I (acute exercise)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Resting</intervention_name>
    <description>Seated resting</description>
    <arm_group_label>Arm II (rest)</arm_group_label>
    <other_name>Rest</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Biomarker Analysis</intervention_name>
    <description>Correlative studies</description>
    <arm_group_label>Arm I (acute exercise)</arm_group_label>
    <arm_group_label>Arm II (rest)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Questionnaire Administration</intervention_name>
    <description>Ancillary studies</description>
    <arm_group_label>Arm I (acute exercise)</arm_group_label>
    <arm_group_label>Arm II (rest)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Current Inclusion Criteria (for Extension participants):&#xD;
&#xD;
          -  Female&#xD;
&#xD;
          -  History of Stage 0-IIIc breast cancer, diagnosed within the last 5 years&#xD;
&#xD;
          -  Completed primary treatment at least 6 months ago&#xD;
&#xD;
          -  Able to attend 2 clinic visits at the Fred Hutch Prevention Center for approximately&#xD;
             2.5 hours at a time&#xD;
&#xD;
          -  Aged 36-75 years. Younger women will be excluded because a sizable proportion may&#xD;
             remain premenopausal and will resume menstruation within 2 years of chemotherapy&#xD;
             completion.&#xD;
&#xD;
          -  Postmenopausal (no menstrual periods in the previous 12 months either naturally, or as&#xD;
             a consequence of treatment)&#xD;
&#xD;
          -  All race and ethnic groups are eligible for the study&#xD;
&#xD;
          -  Able to perform all study requirements, including attendance at clinic visits and&#xD;
             capable of responding to questionnaires and clinic and exercise facility instructions&#xD;
             in English&#xD;
&#xD;
          -  Willing to consent to release of medical records for their breast cancer diagnosis and&#xD;
             treatment&#xD;
&#xD;
          -  If a patient has received a cardiotoxic therapy (e.g., Adriamycin, Herceptin),&#xD;
             clearance of their oncologist to participated in this study will be required.&#xD;
&#xD;
        Previous Inclusion Criteria (for participants enrolled prior to Extension portion of&#xD;
        study):&#xD;
&#xD;
          -  Resident in greater Seattle metropolitan area (King County), Pierce or Snohomish&#xD;
             Counties&#xD;
&#xD;
          -  Healthy&#xD;
&#xD;
          -  Able to perform all study requirements, including attendance at clinic visits and&#xD;
             capable of responding to questionnaires and clinic and exercise facility instructions&#xD;
             in English&#xD;
&#xD;
          -  Willing to be randomized&#xD;
&#xD;
          -  Capable of providing informed consent&#xD;
&#xD;
        Current Exclusion Criteria (for Extension participants):&#xD;
&#xD;
          -  Family history of breast cancer&#xD;
&#xD;
          -  If known, BRCA 1/2 mutation carrier&#xD;
&#xD;
          -  If known, Li-Fraumeni Syndrome&#xD;
&#xD;
          -  Personal history of cancer other than breast: exceptions are non-melanoma skin cancer&#xD;
             and cervical neoplasia (CIN)&#xD;
&#xD;
          -  Serious health conditions including diabetes, renal disease (e.g., chronic kidney&#xD;
             disease), liver disease (e.g., cirrhosis, chronic liver failure), chronic lung disease&#xD;
             (COPD, moderate or severe persistent asthma), auto-immune disease requiring oral or&#xD;
             inhaled medication, congestive heart failure, or other condition likely to interfere&#xD;
             with ability to exercise at moderate levels and undergo biosampling, or likely to&#xD;
             interfere with study outcomes.&#xD;
&#xD;
          -  Fasting glucose fingerstick &gt;126 mg/dL&#xD;
&#xD;
          -  Taking any medications to treat high blood sugar such as metformin&#xD;
&#xD;
          -  Contraindications for exercise testing (29) including: recent (within 6 months)&#xD;
             cardiac event (MI, pulmonary edema, myocarditis, pericarditis), unstable angina,&#xD;
             uncontrolled arrhythmia, third degree heart block, left bundle branch block, acute&#xD;
             congestive failure, recent (within 6 months) pulmonary/systemic embolus, severe&#xD;
             electrolyte abnormality, deep vein thrombosis, uncontrolled hypertension (systolic &gt;&#xD;
             200, diastolic &gt; 100), orthostatic hypotension, moderate/severe aortic stenosis,&#xD;
             uncontrolled arrhythmia, uncontrolled congestive heart failure, history of cardiac&#xD;
             arrest or stroke, or as assessed by the physician assistant during the physical exam.&#xD;
&#xD;
          -  History of clotting disorders&#xD;
&#xD;
          -  Unable or unwilling to stop aspirin or NSAIDs for 48 hours before and after the&#xD;
             procedure&#xD;
&#xD;
          -  Allergy to anesthetics or local anesthetics&#xD;
&#xD;
          -  Long term use of warfarin or similar medications&#xD;
&#xD;
          -  Use of medications that could affect exercise ability, blood biomarkers, or muscle&#xD;
             biomarkers, including weight loss medications, statins, oral beta-blockers,&#xD;
             performance-enhancing drugs, metformin or other diabetic drug, and oral&#xD;
             corticosteroids.&#xD;
&#xD;
          -  Use of any sex hormones (estrogen, progesterone, testosterone or other androgens, for&#xD;
             the previous 3 months) of any type including oral, creams, vaginal creams or inserts,&#xD;
             patches, implants). Participants will be allowed to be on maintenance anti-estrogen&#xD;
             therapy - e.g., tamoxifen, aromatase inhibitors&#xD;
&#xD;
          -  Consumption of (on average) more than 2 alcoholic drinks per day&#xD;
&#xD;
          -  Current use of any tobacco products including smoking, vaping, chew, nicotine patches&#xD;
&#xD;
          -  Frequent marijuana use (&gt;1 per month)&#xD;
&#xD;
          -  Current participation in another randomized controlled trial&#xD;
&#xD;
        Previous Exclusion Criteria (for participants enrolled prior to Extension portion of&#xD;
        study):&#xD;
&#xD;
          -  Pregnant in past 3 months&#xD;
&#xD;
          -  Lactating&#xD;
&#xD;
          -  Premenopausal women: irregular menstrual periods for the previous 6 months; no use of&#xD;
             oral contraceptives for the previous 3 months, no use of hormone implants or&#xD;
             intrauterine device (IUD) for in the previous year, no use of other sex hormones&#xD;
             including testosterone or other androgens for the previous 3 months&#xD;
&#xD;
          -  Postmenopausal women: no use of any sex hormones (estrogen, progesterone, testosterone&#xD;
             or other androgens, for the previous 3 months) of any type including oral, creams,&#xD;
             vaginal creams or inserts, patches, implants&#xD;
&#xD;
          -  Current use of any tobacco products including smoking, vaping, chew, nicotine patches&#xD;
&#xD;
          -  History of diabetes mellitus, or fasting glucose fingerstick ≥ 126 mg/dL&#xD;
&#xD;
          -  Taking any medications to treat high blood sugar such as metformin&#xD;
&#xD;
          -  Personal history of invasive or in situ breast cancer&#xD;
&#xD;
          -  Personal history of cancer other than breast: exceptions are non-melanoma skin cancer&#xD;
             and cervical neoplasia (CIN)&#xD;
&#xD;
          -  ≥ 2 alcoholic drinks/day&#xD;
&#xD;
          -  Contraindications to exercise&#xD;
&#xD;
          -  Abnormalities on screening physical that contraindicate participation&#xD;
&#xD;
          -  Contraindications for entry into a research exercise program: recent (within 6 months)&#xD;
             myocardial infarction, pulmonary edema, myocarditis, pericarditis, unstable angina,&#xD;
             pulmonary embolism, deep vein thrombosis, uncontrolled hypertension (systolic &gt; 200,&#xD;
             diastolic &gt; 100), orthostatic hypotension, moderate/severe aortic stenosis,&#xD;
             uncontrolled arrhythmia, uncontrolled congestive heart failure, left bundle branch&#xD;
             block, history of cardiac arrest or stroke&#xD;
&#xD;
          -  Frequent marijuana use (&gt; 1 per month)&#xD;
&#xD;
          -  Alcohol or drug abuse, significant mental illness (as assessed by study staff&#xD;
             impression)&#xD;
&#xD;
          -  History of clotting disorders (muscle-biopsy sub study)&#xD;
&#xD;
          -  Unable or unwilling to stop aspirin or nonsteroidal antiinflammatory drugs (NSAIDs)&#xD;
             for 48 hours before and after the procedure (muscle-biopsy sub study)&#xD;
&#xD;
          -  Allergy to anesthetics or local anesthetics (muscle-biopsy sub study)&#xD;
&#xD;
          -  Long term use of warfarin or similar medications (muscle-biopsy sub study)&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Anne McTiernan</last_name>
    <role>Principal Investigator</role>
    <affiliation>Fred Hutch/University of Washington Cancer Consortium</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Catherine Duggan</last_name>
    <phone>206-667-2323</phone>
    <email>cduggan@fredhutch.org</email>
  </overall_contact>
  <location>
    <facility>
      <name>Fred Hutch/University of Washington Cancer Consortium</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98109</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Catherine Duggan</last_name>
      <phone>206-667-2323</phone>
      <email>cduggan@fredhutch.org</email>
    </contact>
    <investigator>
      <last_name>Anne McTiernan</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>December 17, 2018</study_first_submitted>
  <study_first_submitted_qc>December 17, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 19, 2018</study_first_posted>
  <last_update_submitted>June 23, 2023</last_update_submitted>
  <last_update_submitted_qc>June 23, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 27, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </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>
  <!-- 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/NCT03779867
org study id: RG1003977
secondary id: NCI-2018-02831
secondary id: 8766
nct id: NCT03779867
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This trial studies how a 45-minute bout of acute exercise in healthy women as well as women
      with a history of breast cancer can affect factors associated with breast cancer and help
      doctors learn more about how exercise can help prevent breast cancer.
OUTLINE: Participants are randomized to 1 of 2 arms.

      ARM I: Participants undergo a moderate-intensity acute exercise bout over 45 minutes.

      ARM II: Participants rest by sitting for 45 minutes.

      EXTENSION: After completion of initial study recruitment and data collection, an extension
      was approved in 2023.

      EXTENSION OUTLINE: Participants are randomized to 1 of 2 arms.

      EXTENSION ARM I: Participants exercise on a stationary bike for 45 minutes.

      EXTENSION ARM II: Participants rest by sitting for 45 minutes.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Double (Investigator, Outcomes Assessor)
masking description: All study personnel other than the statisticians and exercise physiologist will be masked to participant study arm
measure: Mean change in homeostatic model assessment of insulin resistance (HOMA-IR)
time frame: Baseline up to 45 minutes
description: Will compare the average changes in HOMA-IR from baseline to 45 minutes between the exercisers and controls.
measure: Mean change in HOMA-IR
time frame: Baseline up to 105 minutes
description: Will compare the average changes in HOMA-IR from baseline to 105 minutes between the exercisers and controls.
measure: Change in insulin level
time frame: Baseline up to 45 minutes
description: Will compare changes in insulin level from baseline to 45 minutes between the exercisers and controls.
measure: Change in insulin level
time frame: Baseline up to 105 minutes
description: Will compare changes in insulin level from baseline to 105 minutes between the exercisers and controls.
measure: Change in glucose level
time frame: Baseline up to 45 minutes
description: Will compare changes in glucose level from baseline to 45 minutes between the exercisers and controls.
measure: Change in glucose level
time frame: Baseline up to 105 minutes
description: Will compare changes in glucose level from baseline to 105 minutes between the exercisers and controls.
measure: Change in Vascular Endothelial Growth Factor (VEGF) level
time frame: Baseline up to 45 minutes
description: Will compare changes in VEGF level from baseline to 45 minutes between the exercisers and controls.
measure: Change in VEGF level
time frame: Baseline up to 105 minutes
description: Will compare changes in VEGF level from baseline to 105 minutes between the exercisers and controls.
measure: Change in Irisin level
time frame: Baseline up to 45 minutes
description: Will compare changes in Irisin level from baseline to 45 minutes between the exercisers and controls.
measure: Change in Irisin level
time frame: Baseline up to 105 minutes
description: Will compare changes in Irisin level from baseline to 105 minutes between the exercisers and controls.
measure: Change in Plasminogen activator inhibitor type-1 (PAI-1) level
time frame: Baseline up to 45 minutes
description: Will compare changes in PAI-1 level from baseline to 45 minutes between the exercisers and controls.
measure: Change in PAI-1 level
time frame: Baseline up to 105 minutes
description: Will compare changes in PAI-1 level from baseline to 105 minutes between the exercisers and controls.
measure: Effects of exercise on HOMA-IR in normal-weight participants
time frame: At 45 minutes
description: Will use the generalized estimating equations (GEE) model including the potential effect modification of weight category (normal weight versus [vs] overweight/obese) to compare the 45-minute exercise session on HOMA-IR in normal-weight versus overweight/obese women.
measure: Effects of exercise on HOMA-IR in overweight/obese participants
time frame: At 45 minutes
description: Will use the GEE model including the potential effect modification of weight category (normal weight versus [vs.] overweight/obese) to compare the 45-minute exercise session on HOMA-IR in normal-weight versus overweight/obese women.
measure: Change in C-reactive protein (CRP)
time frame: Baseline up to 105 minutes
description: Will compare changes in CRP level from baseline to 105 minutes between the exercisers and controls.
measure: Change in Interleukin (IL)-6
time frame: Baseline up to 105 minutes
description: Will compare changes in IL-6 level from baseline to 105 minutes between the exercisers and controls.
measure: Change in Monocyte chemotactic protein (MCP)-1
time frame: Baseline up to 105 minutes
description: Will compare changes in MCP-1 level from baseline to 105 minutes between the exercisers and controls.
arm group label: Arm I (acute exercise)
arm group type: Experimental
description: Participants undergo a moderate-intensity acute exercise bout over 45 minutes.
arm group label: Arm II (rest)
arm group type: Active Comparator
description: Participants rest by sitting for 45 minutes.
intervention type: Behavioral
intervention name: Exercise Intervention
description: Undergo acute exercise
arm group label: Arm I (acute exercise)
intervention type: Other
intervention name: Resting
description: Seated resting
arm group label: Arm II (rest)
other name: Rest
intervention type: Other
intervention name: Biomarker Analysis
description: Correlative studies
arm group label: Arm I (acute exercise)
arm group label: Arm II (rest)
intervention type: Other
intervention name: Questionnaire Administration
description: Ancillary studies
arm group label: Arm I (acute exercise)
arm group label: Arm II (rest)
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Anne McTiernan
role: Principal Investigator
affiliation: Fred Hutch/University of Washington Cancer Consortium
last name: Catherine Duggan
phone: 206-667-2323
email: cduggan@fredhutch.org
facility: 
status: Recruiting
contact: 
investigator: 
country: United States
responsible party type: Sponsor
mesh term: Breast Neoplasms
sharing ipd: No