<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/NCT03270111</url>
  </required_header>
  <id_info>
    <org_study_id>STUDY00141301</org_study_id>
    <nct_id>NCT03270111</nct_id>
  </id_info>
  <brief_title>High Physical Activity During a Weight Loss Intervention for Breast Cancer Survivors and High Risk Women</brief_title>
  <official_title>High Energy Expenditure From Physical Activity During a Weight Loss Intervention for Breast Cancer Survivors and High Risk Women</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Carol Fabian, MD</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Kansas Medical 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>
      The purpose of this second pilot study is to extend the feasibility demonstrated in&#xD;
      NCT02963740 that the intervention achieves high levels of moderate to vigorous physical&#xD;
      activity (MVI PA) and modulates risk biomarkers for breast cancer and cardiovascular disease&#xD;
      in older, obese sedentary breast cancer survivors who are undergoing moderate calorie&#xD;
      restriction.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      All subjects participate in same intervention. Intervention consists of a 6-month structured&#xD;
      weight loss program utilizing portion controlled meals and a prescribed level of graduated&#xD;
      physical activity with an eventual goal of 200 minutes or more per week. The program will&#xD;
      include twice weekly sessions with a trainer at a local YMCA, and weekly phone group sessions&#xD;
      the first 3 months with transition to unsupervised exercise and less frequent group phone&#xD;
      sessions the second 3 months.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 25, 2017</start_date>
  <completion_date type="Actual">July 24, 2018</completion_date>
  <primary_completion_date type="Actual">July 24, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Adherence to supervised exercise sessions</measure>
    <time_frame>Week 12</time_frame>
    <description>Adherence is defined as the percent of monitored sessions at the YMCA attended by the participant.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percent participants meeting physical activity goal</measure>
    <time_frame>Week 12</time_frame>
    <description>Measured as percentage of participants meeting final physical activity goal between week 9 to week 12. Measurement based off activity tracker participants will wear.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">11</enrollment>
  <condition>Breast Cancer Female</condition>
  <arm_group>
    <arm_group_label>A2: Breast Cancer Survivor</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will include breast cancer survivors who take part in a weight loss intervention program. The intervention is the same for all participants.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>B: High Risk Women</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will include women at high risk of breast cancer who take part in a weight loss intervention program. The intervention is the same for all participants.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Supervised Exercise</intervention_name>
    <description>Participants will take part in supervised exercise activities two times per week at a YMCA. Length of the activity will be increased during participation in study. Participants will start at 40 minutes per week and work their way up to 120 minutes per week.</description>
    <arm_group_label>A2: Breast Cancer Survivor</arm_group_label>
    <arm_group_label>B: High Risk Women</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Home-based Exercise</intervention_name>
    <description>Aerobic exercise activities to be completed at home. Participants will be asked to start out doing 60 minutes at home and work up to 180 minutes of purposeful aerobic home exercise per week.</description>
    <arm_group_label>A2: Breast Cancer Survivor</arm_group_label>
    <arm_group_label>B: High Risk Women</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Reduced Energy Diet</intervention_name>
    <description>Diet is a nutritionally balanced, reduced energy diet recommended by the Academy of Nutrition and Dietetics.</description>
    <arm_group_label>A2: Breast Cancer Survivor</arm_group_label>
    <arm_group_label>B: High Risk Women</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Group Phone Calls</intervention_name>
    <description>Sessions are weekly months 1-3 and every other week months 4-6. The calls will discuss lifestyle changes specific to participants and cover the effects of diet, physical activity, and weight on breast cancer risk, as well as body image and emotional eating.</description>
    <arm_group_label>A2: Breast Cancer Survivor</arm_group_label>
    <arm_group_label>B: High Risk Women</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of breast cancer having completed any cytotoxic chemotherapy, radiation or&#xD;
             surgery at least 3 months prior to study entry (Cohort A2) OR No prior diagnosis of&#xD;
             breast cancer but at high risk for development of breast cancer and participating in&#xD;
             HSC 4601 (Cohort B)&#xD;
&#xD;
          -  Body Mass Index (BMI) &gt;30 kg/m2. Women with a BMI &gt; 45 kg/m2 must be age &lt; 60 and&#xD;
             ability to perform physical activity must be confirmed&#xD;
&#xD;
          -  By self-assessment, currently performing 60 minutes or less of purposeful exercise per&#xD;
             week but able to walk at least 30 minutes on a level surface&#xD;
&#xD;
          -  Possession of smart phone capable of running MyFitnessPal and Garmin Connect apps and&#xD;
             willing to have diet and exercise data accessed by study personnel&#xD;
&#xD;
          -  Access to a personal computer&#xD;
&#xD;
          -  Live in the greater Kansas City Metropolitan Area&#xD;
&#xD;
          -  Willing and able to perform moderate intensity exercise at least 5 days per week for 6&#xD;
             months. This consists of a supervised exercise intervention at one of the 15 YMCAs&#xD;
             affiliated with our program for 2 days per week. Must be willing to perform&#xD;
             unsupervised home exercise for the entire 6 months.&#xD;
&#xD;
          -  Willing to participate in a weekly behavioral modification group phone call for first&#xD;
             3 months and every 2 weeks for the second 3 months&#xD;
&#xD;
          -  Willing to participate in a controlled dietary intervention with portion controlled&#xD;
             meals and partial meal replacements plus 35 servings of fruits and vegetables/week for&#xD;
             6 months and track food intake and exercise&#xD;
&#xD;
          -  Blood tests (Cohort A2) must have been performed after completion of any breast cancer&#xD;
             surgery, radiation therapy, or cytotoxic chemotherapy, with reasonably normal liver&#xD;
             and renal function as well as a hemoglobin of 10 or higher and/or performed within a&#xD;
             year of study entry&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Use of metformin, insulin, steroids or prescription weight loss or anti-psychotic&#xD;
             drugs within the prior 3 weeks&#xD;
&#xD;
          -  Individuals with prior gastric bypass surgery or procedure that would impair&#xD;
             absorption of nutrients&#xD;
&#xD;
          -  Need for chronic immunosuppressive drugs&#xD;
&#xD;
          -  Participation within the past 6 months on a structured weight loss program such as&#xD;
             Weight Watchers®&#xD;
&#xD;
          -  Physical impairments (bad hip, knees, feet, peripheral neuropathy) that would prohibit&#xD;
             performing moderate intensity exercise at least 5 days per week.&#xD;
&#xD;
          -  Any other condition or intercurrent illness that in the opinion of the investigator&#xD;
             makes the subject a poor candidate for participation in the trial such as recent&#xD;
             cardiac event&#xD;
&#xD;
          -  Currently receiving investigational agents in a clinical trial&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Carol Fabian, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Kansas Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Kansas Medical Center</name>
      <address>
        <city>Kansas City</city>
        <state>Kansas</state>
        <zip>66160</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <results_reference>
    <citation>Fabian CJ, Klemp JR, Marchello NJ, Vidoni ED, Sullivan DK, Nydegger JL, Phillips TA, Kreutzjans AL, Hendry B, Befort CA, Nye L, Powers KR, Hursting SD, Giles ED, Hamilton-Reeves JM, Li B, Kimler BF. Rapid Escalation of High-Volume Exercise during Caloric Restriction; Change in Visceral Adipose Tissue and Adipocytokines in Obese Sedentary Breast Cancer Survivors. Cancers (Basel). 2021 Sep 28;13(19):4871. doi: 10.3390/cancers13194871.</citation>
    <PMID>34638355</PMID>
  </results_reference>
  <verification_date>January 2022</verification_date>
  <study_first_submitted>August 30, 2017</study_first_submitted>
  <study_first_submitted_qc>August 30, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 1, 2017</study_first_posted>
  <last_update_submitted>January 9, 2022</last_update_submitted>
  <last_update_submitted_qc>January 9, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">January 25, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University of Kansas Medical Center</investigator_affiliation>
    <investigator_full_name>Carol Fabian, MD</investigator_full_name>
    <investigator_title>Professor, Director Breast Cancer Prevention Unit</investigator_title>
  </responsible_party>
  <keyword>breast cancer survivor</keyword>
  <keyword>weight loss program</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Breast Neoplasms</mesh_term>
    <mesh_term>Weight Loss</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/NCT03270111
org study id: STUDY00141301
nct id: NCT03270111
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this second pilot study is to extend the feasibility demonstrated in
      NCT02963740 that the intervention achieves high levels of moderate to vigorous physical
      activity (MVI PA) and modulates risk biomarkers for breast cancer and cardiovascular disease
      in older, obese sedentary breast cancer survivors who are undergoing moderate calorie
      restriction.
All subjects participate in same intervention. Intervention consists of a 6-month structured
      weight loss program utilizing portion controlled meals and a prescribed level of graduated
      physical activity with an eventual goal of 200 minutes or more per week. The program will
      include twice weekly sessions with a trainer at a local YMCA, and weekly phone group sessions
      the first 3 months with transition to unsupervised exercise and less frequent group phone
      sessions the second 3 months.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Adherence to supervised exercise sessions
time frame: Week 12
description: Adherence is defined as the percent of monitored sessions at the YMCA attended by the participant.
measure: Percent participants meeting physical activity goal
time frame: Week 12
description: Measured as percentage of participants meeting final physical activity goal between week 9 to week 12. Measurement based off activity tracker participants will wear.
arm group label: A2: Breast Cancer Survivor
arm group type: Experimental
description: Participants will include breast cancer survivors who take part in a weight loss intervention program. The intervention is the same for all participants.
arm group label: B: High Risk Women
arm group type: Experimental
description: Participants will include women at high risk of breast cancer who take part in a weight loss intervention program. The intervention is the same for all participants.
intervention type: Behavioral
intervention name: Supervised Exercise
description: Participants will take part in supervised exercise activities two times per week at a YMCA. Length of the activity will be increased during participation in study. Participants will start at 40 minutes per week and work their way up to 120 minutes per week.
arm group label: A2: Breast Cancer Survivor
arm group label: B: High Risk Women
intervention type: Behavioral
intervention name: Home-based Exercise
description: Aerobic exercise activities to be completed at home. Participants will be asked to start out doing 60 minutes at home and work up to 180 minutes of purposeful aerobic home exercise per week.
arm group label: A2: Breast Cancer Survivor
arm group label: B: High Risk Women
intervention type: Behavioral
intervention name: Reduced Energy Diet
description: Diet is a nutritionally balanced, reduced energy diet recommended by the Academy of Nutrition and Dietetics.
arm group label: A2: Breast Cancer Survivor
arm group label: B: High Risk Women
intervention type: Behavioral
intervention name: Group Phone Calls
description: Sessions are weekly months 1-3 and every other week months 4-6. The calls will discuss lifestyle changes specific to participants and cover the effects of diet, physical activity, and weight on breast cancer risk, as well as body image and emotional eating.
arm group label: A2: Breast Cancer Survivor
arm group label: B: High Risk Women
criteria: 
gender: Female
gender based: Yes
minimum age: 50 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Carol Fabian, MD
role: Principal Investigator
affiliation: University of Kansas Medical Center
facility: 
country: United States
citation: Fabian CJ, Klemp JR, Marchello NJ, Vidoni ED, Sullivan DK, Nydegger JL, Phillips TA, Kreutzjans AL, Hendry B, Befort CA, Nye L, Powers KR, Hursting SD, Giles ED, Hamilton-Reeves JM, Li B, Kimler BF. Rapid Escalation of High-Volume Exercise during Caloric Restriction; Change in Visceral Adipose Tissue and Adipocytokines in Obese Sedentary Breast Cancer Survivors. Cancers (Basel). 2021 Sep 28;13(19):4871. doi: 10.3390/cancers13194871.
PMID: 34638355
responsible party type: Sponsor-Investigator
investigator affiliation: University of Kansas Medical Center
investigator full name: Carol Fabian, MD
investigator title: Professor, Director Breast Cancer Prevention Unit
mesh term: Breast Neoplasms
mesh term: Weight Loss
sharing ipd: No