<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/NCT03284346</url>
  </required_header>
  <id_info>
    <org_study_id>0S-17-5</org_study_id>
    <secondary_id>NCI-2017-01426</secondary_id>
    <secondary_id>0S-17-5</secondary_id>
    <secondary_id>P30CA014089</secondary_id>
    <nct_id>NCT03284346</nct_id>
  </id_info>
  <brief_title>Exercise in Targeting Metabolic Dysregulation in Stage I-III Breast or Prostate Cancer Survivors</brief_title>
  <official_title>Circuit, Interval-Based Aerobic and Resistance Exercise to Target Metabolic Dysregulation: The CARE Study for Breast and Prostate Cancer Survivors</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Southern California</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Southern California</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This randomized pilot clinical trial studies how well circuit, interval-based aerobic and&#xD;
      resistance exercise works in targeting metabolic dysregulation in stage I-III breast or&#xD;
      prostate cancer survivors. Circuit, interval-based aerobic and resistance exercise may help&#xD;
      to improve cardiovascular fitness, weight loss, healthy lifestyle behaviors, and muscle&#xD;
      strength in breast or prostate cancer survivors.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PRIMARY OBJECTIVES:&#xD;
&#xD;
      I. To determine the effects of a 4-month circuit, interval-based aerobic and resistance&#xD;
      exercise (CARE) intervention on metabolic dysregulation.&#xD;
&#xD;
      SECONDARY OBJECTIVES:&#xD;
&#xD;
      I. To determine the effects of a 4-month CARE intervention on sarcopenic obesity.&#xD;
&#xD;
      TERTIARY OBJECTIVES:&#xD;
&#xD;
      I. To determine the effects of a 4-month CARE intervention on skeletal muscle strength,&#xD;
      physical fitness, and quality of life (QOL).&#xD;
&#xD;
      II. To determine the effects of a 4-month CARE intervention on vascular function.&#xD;
&#xD;
      OUTLINE: Patients are randomized to 1 of 2 arms.&#xD;
&#xD;
      Arm I: Patients undergo supervised exercise sessions comprised of CARE over 50 minutes 3 days&#xD;
      weekly for 16 weeks. Patients receive a Polar heart rate monitor to monitor heart rate during&#xD;
      the CARE sessions.&#xD;
&#xD;
      Arm II: Patients undergo a standard stretching program 3 days weekly for 16 weeks. After 16&#xD;
      weeks, patients may undergo supervised exercise sessions comprised of CARE as in Arm I.&#xD;
&#xD;
      After completion of study, patients undergoing CARE are followed up for 4 months.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    PI left&#xD;
  </why_stopped>
  <start_date type="Actual">August 17, 2017</start_date>
  <completion_date type="Actual">July 15, 2019</completion_date>
  <primary_completion_date type="Actual">July 15, 2019</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>Change in insulin resistance</measure>
    <time_frame>Baseline up to week 34</time_frame>
    <description>Homeostasis Model Assessment (HOMA) will be used to estimate insulin resistance using fasting plasma levels of glucose and insulin.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in metabolic syndrome (Blood Pressure)</measure>
    <time_frame>Baseline up to week 34</time_frame>
    <description>Blood pressure will be measured using an automated device with an appropriate sized cuff (Omron BP 786, Lake Forest, IL) after the participant has sat quietly for 5 minutes while resting his/her arm on a table so the brachial artery is level with the heart.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in metabolic syndrome (Waist Circumference)</measure>
    <time_frame>Baseline up to week 34</time_frame>
    <description>A tape measure will be used to obtain waist circumference defined as the distance around the waist using the umbilicus as the reference point.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in metabolic syndrome (Fasting Plasma Levels of Glucose)</measure>
    <time_frame>Baseline up to week 34</time_frame>
    <description>The investigators will assess fasting plasma levels of glucose at baseline, weeks 9, 18 and 34.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in metabolic syndrome (High-Density Lipoprotein-Cholesterol)</measure>
    <time_frame>Baseline up to week 34</time_frame>
    <description>The investigators will assess high-density lipoprotein-cholesterol levels at baseline, weeks 9, 18 and 34.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in metabolic syndrome (Triglycerides)</measure>
    <time_frame>Baseline up to week 34</time_frame>
    <description>The investigators will assess triglyceride levels at baseline, weeks 9, 18 and 34.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">23</enrollment>
  <condition>Cancer Survivor</condition>
  <condition>No Evidence of Disease</condition>
  <condition>Obesity</condition>
  <condition>Overweight</condition>
  <condition>Prostate Carcinoma</condition>
  <condition>Sedentary Lifestyle</condition>
  <condition>Stage I Breast Cancer</condition>
  <condition>Stage IA Breast Cancer</condition>
  <condition>Stage IB Breast Cancer</condition>
  <condition>Stage II Breast Cancer</condition>
  <condition>Stage IIA Breast Cancer</condition>
  <condition>Stage IIB Breast Cancer</condition>
  <condition>Stage III Breast Cancer</condition>
  <condition>Stage IIIA Breast Cancer</condition>
  <condition>Stage IIIB Breast Cancer</condition>
  <condition>Stage IIIC Breast Cancer</condition>
  <arm_group>
    <arm_group_label>Arm I (CARE)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients undergo supervised exercise sessions comprised of CARE over 50 minutes 3 days weekly for 16 weeks. Patients receive a Polar heart rate monitor to monitor heart rate during the CARE sessions.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm II (standard stretching)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients undergo a standard stretching program 3 days weekly for 16 weeks. After 16 weeks, patients may undergo supervised exercise sessions comprised of CARE as in Arm I.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Exercise Intervention</intervention_name>
    <description>Undergo CARE</description>
    <arm_group_label>Arm I (CARE)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Exercise Intervention</intervention_name>
    <description>Undergo standard stretching program</description>
    <arm_group_label>Arm II (standard stretching)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Laboratory Biomarker Analysis</intervention_name>
    <description>Correlative studies</description>
    <arm_group_label>Arm I (CARE)</arm_group_label>
    <arm_group_label>Arm II (standard stretching)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Monitoring Device</intervention_name>
    <description>Receive Polar heart rate monitor</description>
    <arm_group_label>Arm I (CARE)</arm_group_label>
    <other_name>Monitor</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Quality-of-Life Assessment</intervention_name>
    <description>Ancillary studies</description>
    <arm_group_label>Arm I (CARE)</arm_group_label>
    <arm_group_label>Arm II (standard stretching)</arm_group_label>
    <other_name>Quality of Life Assessment</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Questionnaire Administration</intervention_name>
    <description>Ancillary studies</description>
    <arm_group_label>Arm I (CARE)</arm_group_label>
    <arm_group_label>Arm II (standard stretching)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  BREAST CANCER COHORT:&#xD;
&#xD;
          -  Women newly diagnosed (stage I-III) breast cancer&#xD;
&#xD;
          -  Are overweight or obese with the following criteria (determined by study team at&#xD;
             eligibility screening): body mass index (BMI) &gt; 25 kg/m^2 (calculated using height and&#xD;
             weight; an upper limit BMI will not be set; we will rely on obtaining physicians?&#xD;
             clearance to assess full eligibility) or body fat &gt; 30% (estimated by bioelectrical&#xD;
             impedance), and waist circumference &gt; 35 in&#xD;
&#xD;
          -  Have undergone a lumpectomy or mastectomy&#xD;
&#xD;
          -  Have completed cancer-related treatment within the past 3 years&#xD;
&#xD;
          -  Speak English or Spanish&#xD;
&#xD;
          -  Are in breast cancer remission with no detectable disease present&#xD;
&#xD;
          -  Able to initiate a supervised exercise program (free from any cardiovascular,&#xD;
             respiratory or musculoskeletal disease or joint problems that preclude moderate&#xD;
             physical activity)&#xD;
&#xD;
          -  Free from history of chronic disease including uncontrolled diabetes (fasting blood&#xD;
             glucose &gt; 125 mg/dL), hypertension (blood pressure &gt; 130/90 mmHg) or thyroid disease&#xD;
             (&lt; 0.4 or &gt; 4.0 mIU/L); this will be determined by review of medical records and/or&#xD;
             physician clearance&#xD;
&#xD;
          -  Have not experienced a weight reduction &gt;= 10% within past 6 months&#xD;
&#xD;
          -  Currently participate in less than 60 minutes of structured exercise/week&#xD;
&#xD;
          -  No planned reconstructive surgery with flap repair during trial and follow-up period&#xD;
&#xD;
          -  May use adjuvant endocrine therapy if use will be continued for duration of study&#xD;
             intervention&#xD;
&#xD;
          -  Do not smoke (no smoking during previous 12 months)&#xD;
&#xD;
          -  Willing to travel to the exercise facility at University of Southern California (USC)&#xD;
&#xD;
          -  PROSTATE CANCER COHORT:&#xD;
&#xD;
          -  Men &gt; 18 diagnosed with prostate cancer for which antiandrogen therapy (ADT)&#xD;
             (castration therapy) is being prescribed for at least 16 weeks; castration may be&#xD;
             achieved surgically or using gonadotrophin releasing hormone (LHRH) agonists (i.e.&#xD;
             leuprolide, goserelin, etc.) or LHRH antagonists (i.e. degarelix)&#xD;
&#xD;
          -  Additional ADT agents may be concurrently administered (abiraterone, bicalutamide,&#xD;
             enzalutamide, etc.)&#xD;
&#xD;
          -  Men must be obese (BMI &gt; 25) and sedentary (&lt; 60 minutes of structured exercise per&#xD;
             week)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with metastatic disease (BREAST ONLY)&#xD;
&#xD;
          -  Have not completed surgery, chemotherapy, or radiation treatment associated with their&#xD;
             diagnosis; a washout period of a minimum of 6 weeks is required from the last&#xD;
             anti-cancer treatment received except hormonal therapy&#xD;
&#xD;
          -  Patients with a history of any musculoskeletal, cardiorespiratory or neurological&#xD;
             diseases that preclude the participation in exercise must be evaluated by their&#xD;
             physician to assess if they are suitable to proceed on study&#xD;
&#xD;
          -  Are planning reconstructive surgery with flap repair during trial and follow-up period&#xD;
&#xD;
          -  Are unable to travel to the exercise facility at USC&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Christina Dieli-Conwright, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Southern California</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>USC / Norris Comprehensive Cancer Center</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90033</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>August 19, 2017</study_first_submitted>
  <study_first_submitted_qc>September 12, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 15, 2017</study_first_posted>
  <last_update_submitted>May 9, 2020</last_update_submitted>
  <last_update_submitted_qc>May 9, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 12, 2020</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>
    <mesh_term>Overweight</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/NCT03284346
org study id: 0S-17-5
secondary id: NCI-2017-01426
secondary id: 0S-17-5
secondary id: P30CA014089
nct id: NCT03284346
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
This randomized pilot clinical trial studies how well circuit, interval-based aerobic and
      resistance exercise works in targeting metabolic dysregulation in stage I-III breast or
      prostate cancer survivors. Circuit, interval-based aerobic and resistance exercise may help
      to improve cardiovascular fitness, weight loss, healthy lifestyle behaviors, and muscle
      strength in breast or prostate cancer survivors.
PRIMARY OBJECTIVES:

      I. To determine the effects of a 4-month circuit, interval-based aerobic and resistance
      exercise (CARE) intervention on metabolic dysregulation.

      SECONDARY OBJECTIVES:

      I. To determine the effects of a 4-month CARE intervention on sarcopenic obesity.

      TERTIARY OBJECTIVES:

      I. To determine the effects of a 4-month CARE intervention on skeletal muscle strength,
      physical fitness, and quality of life (QOL).

      II. To determine the effects of a 4-month CARE intervention on vascular function.

      OUTLINE: Patients are randomized to 1 of 2 arms.

      Arm I: Patients undergo supervised exercise sessions comprised of CARE over 50 minutes 3 days
      weekly for 16 weeks. Patients receive a Polar heart rate monitor to monitor heart rate during
      the CARE sessions.

      Arm II: Patients undergo a standard stretching program 3 days weekly for 16 weeks. After 16
      weeks, patients may undergo supervised exercise sessions comprised of CARE as in Arm I.

      After completion of study, patients undergoing CARE are followed up for 4 months.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Change in insulin resistance
time frame: Baseline up to week 34
description: Homeostasis Model Assessment (HOMA) will be used to estimate insulin resistance using fasting plasma levels of glucose and insulin.
measure: Change in metabolic syndrome (Blood Pressure)
time frame: Baseline up to week 34
description: Blood pressure will be measured using an automated device with an appropriate sized cuff (Omron BP 786, Lake Forest, IL) after the participant has sat quietly for 5 minutes while resting his/her arm on a table so the brachial artery is level with the heart.
measure: Change in metabolic syndrome (Waist Circumference)
time frame: Baseline up to week 34
description: A tape measure will be used to obtain waist circumference defined as the distance around the waist using the umbilicus as the reference point.
measure: Change in metabolic syndrome (Fasting Plasma Levels of Glucose)
time frame: Baseline up to week 34
description: The investigators will assess fasting plasma levels of glucose at baseline, weeks 9, 18 and 34.
measure: Change in metabolic syndrome (High-Density Lipoprotein-Cholesterol)
time frame: Baseline up to week 34
description: The investigators will assess high-density lipoprotein-cholesterol levels at baseline, weeks 9, 18 and 34.
measure: Change in metabolic syndrome (Triglycerides)
time frame: Baseline up to week 34
description: The investigators will assess triglyceride levels at baseline, weeks 9, 18 and 34.
arm group label: Arm I (CARE)
arm group type: Experimental
description: Patients undergo supervised exercise sessions comprised of CARE over 50 minutes 3 days weekly for 16 weeks. Patients receive a Polar heart rate monitor to monitor heart rate during the CARE sessions.
arm group label: Arm II (standard stretching)
arm group type: Active Comparator
description: Patients undergo a standard stretching program 3 days weekly for 16 weeks. After 16 weeks, patients may undergo supervised exercise sessions comprised of CARE as in Arm I.
intervention type: Behavioral
intervention name: Exercise Intervention
description: Undergo CARE
arm group label: Arm I (CARE)
intervention type: Behavioral
intervention name: Exercise Intervention
description: Undergo standard stretching program
arm group label: Arm II (standard stretching)
intervention type: Other
intervention name: Laboratory Biomarker Analysis
description: Correlative studies
arm group label: Arm I (CARE)
arm group label: Arm II (standard stretching)
intervention type: Device
intervention name: Monitoring Device
description: Receive Polar heart rate monitor
arm group label: Arm I (CARE)
other name: Monitor
intervention type: Other
intervention name: Quality-of-Life Assessment
description: Ancillary studies
arm group label: Arm I (CARE)
arm group label: Arm II (standard stretching)
other name: Quality of Life Assessment
intervention type: Other
intervention name: Questionnaire Administration
description: Ancillary studies
arm group label: Arm I (CARE)
arm group label: Arm II (standard stretching)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Christina Dieli-Conwright, Ph.D.
role: Principal Investigator
affiliation: University of Southern California
facility: 
country: United States
responsible party type: Sponsor
mesh term: Breast Neoplasms
mesh term: Overweight