<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/NCT03243786</url>
  </required_header>
  <id_info>
    <org_study_id>PRO00027661</org_study_id>
    <nct_id>NCT03243786</nct_id>
  </id_info>
  <brief_title>Stay on Track: A Study of Exercise Effects During Radiation</brief_title>
  <official_title>Stay on Track: A Pilot Study of the Effects of Exercise on Mitigating Side Effects and Altering Inflammatory Biomarker Profiles During Radiation Therapy for Breast Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medical College of Wisconsin</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medical College of Wisconsin</source>
  <oversight_info>
    <has_dmc>Yes</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 study is to examine the impact of a lifestyle intervention. The study&#xD;
      will examine the Stay on Track program, dietary and activity patterns, body composition,&#xD;
      biomarkers and quality of life in breast cancer patients undergoing radiation therapy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Research Design. The investigators will be conducting an randomized trial in 60 women&#xD;
      undergoing radiation treatment for breast cancer to examine the feasibility of a 12-week&#xD;
      lifestyle intervention that addresses diet and physical activity and to explore the impact on&#xD;
      behavioral, biological and psychosocial outcomes.&#xD;
&#xD;
      Procedure Summary. Patients who are eligible are consented by the research coordinator, after&#xD;
      which a baseline assessment will be scheduled. The baseline assessment requires 60 minutes&#xD;
      and includes questionnaires, height/weight, dual energy x-ray absorptiometry (DEXA), and&#xD;
      phlebotomy. Participants will also wear the Fitbit for one week to establish baseline&#xD;
      activity level. After the baseline assessment, women are then randomly assigned to: the&#xD;
      12-week &quot;Stay on Track&quot; lifestyle intervention or the 12-week self-guided control. Both&#xD;
      groups complete a post-intervention and a 3-month follow-up visit identical to their baseline&#xD;
      assessment. Self-guided controls can utilize their Fitbit and will receive informative&#xD;
      binders 24 weeks' post-intervention.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 12, 2017</start_date>
  <completion_date type="Actual">October 31, 2018</completion_date>
  <primary_completion_date type="Actual">September 1, 2018</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>Percent time of personal fitness tracker use during the intervention period for the Stay on Track intervention arm</measure>
    <time_frame>6 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percent of participant retention thoughout the 12-week intervention through the six month follow-up</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The percent of eligible patient who choose to take part in the study</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of personal exercise sessions were attended by members in the Stay on Track Intervention Arm</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in lean soft tissue over the study period associated with intervention and activity</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in BMI (weight and height will be combined to report BMI in kg/m^2) over the study period associated with intervention and activity</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Measures of physical activity (self-report and objective)</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dietary intake (assessed via Full Length Block Questionnaire)</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Measures of fatigue (Piper Fatigue Scale Score and physician CTCAE v4.0 Scoring)</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Measures of skin side effects (CTCAE v4.0 Scoring)</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life (FACT-B Questionnaire) over the study period associated with intervention and activity</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Measures of pain (PROMIS Scale v1.0- Pain Intensity 3a Questionnaire) over the study period associated with intervention and activity</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in biomarker (GM-CSF) associated with intervention and activity</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in biomarker (IFN-gamma) associated with intervention and activity</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in biomarker (IL-1alpha) associated with intervention and activity</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in biomarker (IL-1beta) associated with intervention and activity</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in biomarker (IL-4) associated with intervention and activity</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in biomarker (IL-6) associated with intervention and activity</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in biomarker (IL-8) associated with intervention and activity</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in biomarker (IL-10) associated with intervention and activity</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in biomarker (IL-12) associated with intervention and activity</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in biomarker (MCP-1) associated with intervention and activity</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in biomarker (TNF-alpha) associated with intervention and activity</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in biomarker (adiponectin) associated with intervention and activity</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in biomarker (leptin) associated with intervention and activity</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in biomarker (CRP) associated with intervention and activity</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in blood insulin level associated with intervention and activity</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in blood hemoglobin A1C level associated with intervention and activity</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in blood glucose level associated with intervention and activity</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">47</enrollment>
  <condition>Breast Cancer</condition>
  <arm_group>
    <arm_group_label>12-week &quot;Stay on Track&quot; intervention</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The study intervention includes three personal exercise training sessions, three dietary counseling sessions, use of a physical activity tracking device, and approximately three weekly text messaging</description>
  </arm_group>
  <arm_group>
    <arm_group_label>12-week self-guided control</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The self guided group does not receive the study intervention, but is offered a Nutrition and wellness guide at the end of 6 months</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Lifestyle- Supportive Care</intervention_name>
    <description>The intervention examines dietary and activity patterns, body composition, biomarkers and quality of life in breast cancer patients undergoing radiation therapy</description>
    <arm_group_label>12-week &quot;Stay on Track&quot; intervention</arm_group_label>
    <arm_group_label>12-week self-guided control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. &gt; 18 years of age;&#xD;
&#xD;
          2. confirmed primary non-metastatic breast adenocarcinoma;&#xD;
&#xD;
          3. planned lumpectomy/segmentectomy/partial mastectomy surgery for primary breast cancer;&#xD;
&#xD;
          4. planning to undergo adjuvant whole breast radiation therapy following a lumpectomy;&#xD;
&#xD;
          5. Have a Karnovsky Performance Score of 70 or above (see Appendix)&#xD;
&#xD;
          6. Patient's Body Mass Index (BMI) is greater than determine by the treating physician,&#xD;
             not currently meeting physical activity guidelines: moderate physical activity for at&#xD;
             least 30 minutes at least five days a week AND 2 weekly sessions of resistance&#xD;
             exercise;&#xD;
&#xD;
          7. have access to a mobile phone with capacity for text messaging (either unlimited or&#xD;
             aware and accepting of text messaging charges);&#xD;
&#xD;
          8. understand and speak English;&#xD;
&#xD;
          9. physically able to engage in the intervention;&#xD;
&#xD;
         10. accepting of randomization (Note that anti-estrogen therapy is allowed.)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients who have metastatic disease;&#xD;
&#xD;
          2. Patients with a history of prior malignancy within the past 3 years, other than&#xD;
             non-melanoma skin cancer.&#xD;
&#xD;
          3. Patients with serious orthopedic, cardiovascular, or pulmonary conditions, have&#xD;
             serious psychiatric or cognitive problems.&#xD;
&#xD;
          4. Patients who have received chemotherapy for their breast cancer.&#xD;
&#xD;
          5. Patients with prior radiotherapy to primary site or adjacent site that results in&#xD;
             overlapping radiation fields.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Female Breast Cancer</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Carmen Bergom, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Medical College of Wisconsin</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Medical College of Wisconsin</name>
      <address>
        <city>Milwaukee</city>
        <state>Wisconsin</state>
        <zip>53226</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2021</verification_date>
  <study_first_submitted>February 16, 2017</study_first_submitted>
  <study_first_submitted_qc>August 7, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 9, 2017</study_first_posted>
  <last_update_submitted>November 18, 2021</last_update_submitted>
  <last_update_submitted_qc>November 18, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">November 30, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Medical College of Wisconsin</investigator_affiliation>
    <investigator_full_name>John Longo</investigator_full_name>
    <investigator_title>Assistant Professor Radiation Oncology</investigator_title>
  </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/NCT03243786
org study id: PRO00027661
nct id: NCT03243786
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to examine the impact of a lifestyle intervention. The study
      will examine the Stay on Track program, dietary and activity patterns, body composition,
      biomarkers and quality of life in breast cancer patients undergoing radiation therapy.
Research Design. The investigators will be conducting an randomized trial in 60 women
      undergoing radiation treatment for breast cancer to examine the feasibility of a 12-week
      lifestyle intervention that addresses diet and physical activity and to explore the impact on
      behavioral, biological and psychosocial outcomes.

      Procedure Summary. Patients who are eligible are consented by the research coordinator, after
      which a baseline assessment will be scheduled. The baseline assessment requires 60 minutes
      and includes questionnaires, height/weight, dual energy x-ray absorptiometry (DEXA), and
      phlebotomy. Participants will also wear the Fitbit for one week to establish baseline
      activity level. After the baseline assessment, women are then randomly assigned to: the
      12-week "Stay on Track" lifestyle intervention or the 12-week self-guided control. Both
      groups complete a post-intervention and a 3-month follow-up visit identical to their baseline
      assessment. Self-guided controls can utilize their Fitbit and will receive informative
      binders 24 weeks' post-intervention.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Percent time of personal fitness tracker use during the intervention period for the Stay on Track intervention arm
time frame: 6 months
measure: Percent of participant retention thoughout the 12-week intervention through the six month follow-up
time frame: 6 months
measure: The percent of eligible patient who choose to take part in the study
time frame: 6 months
measure: Number of personal exercise sessions were attended by members in the Stay on Track Intervention Arm
time frame: 6 months
measure: Changes in lean soft tissue over the study period associated with intervention and activity
time frame: 6 months
measure: Changes in BMI (weight and height will be combined to report BMI in kg/m^2) over the study period associated with intervention and activity
time frame: 6 months
measure: Measures of physical activity (self-report and objective)
time frame: 6 months
measure: Dietary intake (assessed via Full Length Block Questionnaire)
time frame: 6 months
measure: Measures of fatigue (Piper Fatigue Scale Score and physician CTCAE v4.0 Scoring)
time frame: 6 months
measure: Measures of skin side effects (CTCAE v4.0 Scoring)
time frame: 6 months
measure: Quality of life (FACT-B Questionnaire) over the study period associated with intervention and activity
time frame: 6 months
measure: Measures of pain (PROMIS Scale v1.0- Pain Intensity 3a Questionnaire) over the study period associated with intervention and activity
time frame: 6 months
measure: Changes in biomarker (GM-CSF) associated with intervention and activity
time frame: 6 months
measure: Changes in biomarker (IFN-gamma) associated with intervention and activity
time frame: 6 months
measure: Changes in biomarker (IL-1alpha) associated with intervention and activity
time frame: 6 months
measure: Changes in biomarker (IL-1beta) associated with intervention and activity
time frame: 6 months
measure: Changes in biomarker (IL-4) associated with intervention and activity
time frame: 6 months
measure: Changes in biomarker (IL-6) associated with intervention and activity
time frame: 6 months
measure: Changes in biomarker (IL-8) associated with intervention and activity
time frame: 6 months
measure: Changes in biomarker (IL-10) associated with intervention and activity
time frame: 6 months
measure: Changes in biomarker (IL-12) associated with intervention and activity
time frame: 6 months
measure: Changes in biomarker (MCP-1) associated with intervention and activity
time frame: 6 months
measure: Changes in biomarker (TNF-alpha) associated with intervention and activity
time frame: 6 months
measure: Changes in biomarker (adiponectin) associated with intervention and activity
time frame: 6 months
measure: Changes in biomarker (leptin) associated with intervention and activity
time frame: 6 months
measure: Changes in biomarker (CRP) associated with intervention and activity
time frame: 6 months
measure: Changes in blood insulin level associated with intervention and activity
time frame: 6 months
measure: Changes in blood hemoglobin A1C level associated with intervention and activity
time frame: 6 months
measure: Changes in blood glucose level associated with intervention and activity
time frame: 6 months
arm group label: 12-week "Stay on Track" intervention
arm group type: Active Comparator
description: The study intervention includes three personal exercise training sessions, three dietary counseling sessions, use of a physical activity tracking device, and approximately three weekly text messaging
arm group label: 12-week self-guided control
arm group type: Active Comparator
description: The self guided group does not receive the study intervention, but is offered a Nutrition and wellness guide at the end of 6 months
intervention type: Behavioral
intervention name: Lifestyle- Supportive Care
description: The intervention examines dietary and activity patterns, body composition, biomarkers and quality of life in breast cancer patients undergoing radiation therapy
arm group label: 12-week "Stay on Track" intervention
arm group label: 12-week self-guided control
criteria: 
gender: Female
gender based: Yes
gender description: Female Breast Cancer
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Carmen Bergom, MD
role: Principal Investigator
affiliation: Medical College of Wisconsin
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Medical College of Wisconsin
investigator full name: John Longo
investigator title: Assistant Professor Radiation Oncology
mesh term: Breast Neoplasms
sharing ipd: No