<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/NCT02224807</url>
  </required_header>
  <id_info>
    <org_study_id>R21CA178359-01A1</org_study_id>
    <nct_id>NCT02224807</nct_id>
  </id_info>
  <brief_title>Effects of Diet and Exercise on Ductal Carcinoma in Situ</brief_title>
  <acronym>DCIS</acronym>
  <official_title>Exploring Effects of Weight Loss on Ductal Carcinoma In Situ</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Alabama at Birmingham</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Alabama at Birmingham</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This pilot/feasibility trial seeks to explore whether an acute bout of negative energy&#xD;
      balance prior to surgery affects biomarkers of neoplasia. Forty overweight or obese&#xD;
      postmenopausal women diagnosed with ductal carcinoma in situ (DCIS) or early stage breast&#xD;
      cancer (Stage I or II) who elect mastectomy or lumpectomy will be randomly assigned to 1-of-2&#xD;
      study arms: 1) an Attention Control Group that receives instruction on dietary approaches to&#xD;
      correct nutritional deficiencies and progressive resistance training (PRT) that targets the&#xD;
      arm ipsilateral to the affected breast; or 2) an Experimental Group that will receive PRT and&#xD;
      guidance to correct nutritional deficiencies plus an intensive intervention to promote a&#xD;
      1.5-2 pound/week weight loss through diet, exercise, and behavior modification. This study&#xD;
      will explore and contrast changes in body mass index (BMI) observed from enrollment to the&#xD;
      time of surgery in the experimental vs. attention control arms, and also monitor changes in&#xD;
      energy intake and physical activity. These changes will be studied in relation to the&#xD;
      following endpoints: a) changes in select circulating biomarkers and gene expression related&#xD;
      to cancer progression, hormonal status, inflammation and other energy-related factors; b)&#xD;
      rates of tumor proliferation and apoptosis; c) tumor markers, e.g., insulin receptor,&#xD;
      Vascular Epithelial Growth Factor (VEGF), Nuclear Factor kappa beta (NFkB), and&#xD;
      phosphoproteins associated with the Convergence of Hormones, Inflammation and Energy-Rated&#xD;
      Factors (CHIEF) pathway; and d) functional and health-related outcomes. Because both tumor&#xD;
      tissue and blood will be examined from pre-to-post-intervention, this study will provide&#xD;
      exciting new data that can elucidate pathways by which energy balance affects breast cancer&#xD;
      progression. Although longer term weight loss is recommended for overweight and obese breast&#xD;
      cancer survivors, it is not known whether placing the body in a state of negative energy&#xD;
      balance will have a favorable impact on the tumor. If beneficial changes in tumor biology and&#xD;
      the host environment occur with short-term, pre-surgical weight loss, this study provides&#xD;
      proof of concept that weight loss may offer an acceptable and complementary treatment option&#xD;
      that could be combined with standard therapies.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Obesity is a known risk factor for invasive breast cancers that occur post-menopause. Obese&#xD;
      women also die twice as frequently from breast cancer than those of normal weight. Numerous&#xD;
      preclinical studies show the benefits of caloric restriction on cancer progression in animals&#xD;
      - but, will similar effects be seen in humans? In response to a call for translational&#xD;
      studies that will identify biological/biobehavioral pathways through which weight loss may&#xD;
      affect cancer prognosis (PAR-12-229), the investigators propose a pilot study that builds on&#xD;
      the investigators success of pre-surgical interventions to answer the research question,&#xD;
      &quot;does negative energy balance with concomitant weight loss invoke anti-cancer effects on&#xD;
      tumor biology and the host environment?&quot; The investigators will randomly assign 40 overweight&#xD;
      or obese postmenopausal women diagnosed with ductal carcinoma in situ (DCIS) or early stage&#xD;
      breast cancer who elect mastectomy or lumpectomy to 1-of-2 study arms: 1) an Attention&#xD;
      Control Group that receives instruction on dietary approaches to correct nutritional&#xD;
      deficiencies and progressive resistance training (PRT) that targets the arm ipsilateral to&#xD;
      the affected breast; or 2) an Experimental Group that will receive PRT and guidance to&#xD;
      correct nutritional deficiencies plus an intensive intervention to promote a 1.5-2 pound/week&#xD;
      weight loss through diet, exercise, and behavior modification. This study will explore and&#xD;
      contrast changes in body mass index (BMI) observed from enrollment to the time of surgery in&#xD;
      the experimental vs. attention control arms, and also monitor changes in energy intake and&#xD;
      physical activity. These changes will be studied in relation to the following endpoints: a)&#xD;
      changes in select circulating biomarkers and gene expression related to cancer progression,&#xD;
      hormonal status, inflammation and other energy-related factors; b) rates of tumor&#xD;
      proliferation and apoptosis; c) tumor markers, e.g., insulin receptor, Vascular Epithelial&#xD;
      Growth Factor (VEGF), Nuclear Factor kappa beta (NFkB), and phosphoproteins associated with&#xD;
      the Convergence of Hormones, Inflammation and Energy-Rated Factors (CHIEF) pathway; and d)&#xD;
      functional and health-related outcomes. Because both tumor tissue and blood will be examined&#xD;
      from pre-to-post-intervention, this study will provide exciting new data that can elucidate&#xD;
      pathways by which energy balance affects breast cancer progression from a non-invasive to an&#xD;
      invasive state. Although longer term weight loss is recommended for overweight and obese&#xD;
      breast cancer survivors, it is not known whether placing the body in a state of negative&#xD;
      energy balance will have a favorable impact on the tumor. If beneficial changes in tumor&#xD;
      biology and the host environment occur with short-term, pre-surgical weight loss, this study&#xD;
      provides proof of concept that weight loss may offer an acceptable and complementary&#xD;
      treatment option that could be combined with standard therapies. Thus, the research that is&#xD;
      proposed will not only increase the investigators understanding of the impact of negative&#xD;
      energy balance on tumor biology, but could change the standard of care and offer a more&#xD;
      conservative treatment option for the 50,000 American women who are diagnosed with DCIS each&#xD;
      year, as well as a novel adjunct therapy for women with early stage invasive disease.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">July 2018</completion_date>
  <primary_completion_date type="Actual">July 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>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Tumor proliferation</measure>
    <time_frame>Baseline to Time of Surgery</time_frame>
    <description>Ki-67 will be used to determine tumor proliferation. Ki-67 is a cancer antigen that is found in growing, dividing cells but is absent in the resting phase of cell growth. This characteristic makes Ki-67 a good tumor marker. This test is done on a sample of tumor tissue, to help predict prognosis. High levels of Ki-67 indicate an aggressive tumor and predict a poor prognosis. High scores mean that the cancer cells are growing and dividing at a rapid pace. The Ki-67 scores will be compared between arms.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Weight</measure>
    <time_frame>Baseline to Time of Surgery</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Feasibility</measure>
    <time_frame>Baseline to Time of Surgery</time_frame>
    <description>Enroll 40 subjects within 2-year study, retain &gt;80% of the sample and completion &gt;70% of contact sessions.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Body Composition</measure>
    <time_frame>Baseline to Time of Surgery</time_frame>
    <description>Via Dual Energy Absorptiometry (DXA)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Waist Circumference</measure>
    <time_frame>Baseline to Time of Surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tumor markers</measure>
    <time_frame>Baseline to Time of Surgery</time_frame>
    <description>Tumor Markers on the CHIEF (Convergence of Hormonal, Inflammatory and Energy-related Factors) Pathway, e.g., Insulin Receptor, Vascular Endothelial Growth Factor (VEGF), Tumor Necrosis Factor alpha (TNF-alpha), Nuclear Factor Kappa Beta (NFKB), caspase-3, as well as various phosphoproteins.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serum Biomarkers</measure>
    <time_frame>Baseline to Time of Surgery</time_frame>
    <description>Insulin, leptin, Sex Hormone Binding Globulin, VEGF, TNF-alpha</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Gene expression</measure>
    <time_frame>Baseline to Time of Surgery</time_frame>
    <description>Select genes on the CHIEF pathway as well as ~47,231 curated and putative genes and expressed sequence tags (ESTs)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dietary Intake</measure>
    <time_frame>Baseline to Time of Surgery</time_frame>
    <description>24-hour recalls to assess kcal intake as well as intake of fat, protein, and carbohydrate and diet quality</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical Activity</measure>
    <time_frame>Baseline to Time of Surgery</time_frame>
    <description>Assessed via accelerometry as well as via questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of Life</measure>
    <time_frame>Baseline to Time of Surgery</time_frame>
    <description>Using the FACT-B</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cardiorespiratory Fitness</measure>
    <time_frame>Baseline to Time of Surgery</time_frame>
    <description>Sub-maximal testing and a modified version of the Naughton Protocol</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">32</enrollment>
  <condition>Ductal Carcinoma In Situ</condition>
  <condition>Breast Cancer</condition>
  <arm_group>
    <arm_group_label>Progressive Resistance Training (PRT) and a healthy diet</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>PRT will be done with resistance bands; participants will receive instruction on three resistance band exercises (triceps, biceps, and shoulder overhead) from an American College of Sports Medicine (ACSM) certified exercise specialist. Participants also will receive dietary counseling from a registered dietitian on correcting nutrient deficiencies that are detected during analysis of their 2-day dietary recalls.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>PRT and a healthy diet, plus weight loss</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This arm will receive all components of the active comparator arm, plus counseling to achieve a weight loss of 1.5-2 pounds/week. Participants will be trained on how to achieve this caloric deficit through both dietary restriction and increased physical activity. Weight loss will be promoted via a healthy, nutritionally adequate diet consistent with American Cancer Society guidelines. Protein levels will be based on 0.8 g/kg body weight. The distribution of food groups will be customized for preferences. An exercise program will be tailored taking into account kcal expenditure for various activities at a specific body weight; expenditures of 200-400 kcal/day will serve as a goal. Aerobic training of large muscles (legs) will be emphasized to achieve a greater kcal deficit; ramping of intensity and volume over time will be pursued as per the ACSM guidelines. Participants will train once weekly while supervised by an exercise physiologist and daily at home.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Active Comparator: Progressive Resistance Training (PRT) and a healthy diet</intervention_name>
    <description>no additional information; see arm description</description>
    <arm_group_label>Progressive Resistance Training (PRT) and a healthy diet</arm_group_label>
    <other_name>Diet; Exercise; Physical activity</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Experimental: PRT and a healthy diet, plus weight loss</intervention_name>
    <description>no additional information, see arm description</description>
    <arm_group_label>PRT and a healthy diet, plus weight loss</arm_group_label>
    <other_name>Diet; Exercise, Physical Activity</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Postmenopausal women with intermediate-to-high nuclear grade DCIS or stage I or II&#xD;
             breast cancer who elect surgery and who have &gt;3-week lag-time between the start of the&#xD;
             intervention and their scheduled surgery;&#xD;
&#xD;
          -  Overweight or obese (BMI:25-60);&#xD;
&#xD;
          -  English speaking/reading&#xD;
&#xD;
          -  Willing to be assigned to either study arm&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Have a pre-existing medical condition(s) that preclude adherence to unsupervised&#xD;
             exercise;&#xD;
&#xD;
          -  Have a current medical condition that affects weight status;&#xD;
&#xD;
          -  Has an active malignancy, other than DCIS, invasive breast cancer, or non-melanoma&#xD;
             skin cancer;&#xD;
&#xD;
          -  Currently enrolled in a weight loss program&#xD;
&#xD;
          -  Have received or scheduled to receive neoadjuvant chemotherapy prior to mastectomy or&#xD;
             lumpectomy&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Wendy Demark-Wahnefried, PhD, RD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Alabama at Birmingham</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Alabama at Birmingham</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35294</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2018</verification_date>
  <study_first_submitted>August 19, 2014</study_first_submitted>
  <study_first_submitted_qc>August 21, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 25, 2014</study_first_posted>
  <last_update_submitted>August 29, 2018</last_update_submitted>
  <last_update_submitted_qc>August 29, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">August 31, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Alabama at Birmingham</investigator_affiliation>
    <investigator_full_name>Wendy Demark-Wahnefried, PhD</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>breast cancer</keyword>
  <keyword>diet</keyword>
  <keyword>exercise</keyword>
  <keyword>weight loss</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carcinoma</mesh_term>
    <mesh_term>Carcinoma in Situ</mesh_term>
    <mesh_term>Carcinoma, Ductal</mesh_term>
    <mesh_term>Carcinoma, Intraductal, Noninfiltrating</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/NCT02224807
org study id: R21CA178359-01A1
nct id: NCT02224807
lead sponsor: 
has dmc: Yes
This pilot/feasibility trial seeks to explore whether an acute bout of negative energy
      balance prior to surgery affects biomarkers of neoplasia. Forty overweight or obese
      postmenopausal women diagnosed with ductal carcinoma in situ (DCIS) or early stage breast
      cancer (Stage I or II) who elect mastectomy or lumpectomy will be randomly assigned to 1-of-2
      study arms: 1) an Attention Control Group that receives instruction on dietary approaches to
      correct nutritional deficiencies and progressive resistance training (PRT) that targets the
      arm ipsilateral to the affected breast; or 2) an Experimental Group that will receive PRT and
      guidance to correct nutritional deficiencies plus an intensive intervention to promote a
      1.5-2 pound/week weight loss through diet, exercise, and behavior modification. This study
      will explore and contrast changes in body mass index (BMI) observed from enrollment to the
      time of surgery in the experimental vs. attention control arms, and also monitor changes in
      energy intake and physical activity. These changes will be studied in relation to the
      following endpoints: a) changes in select circulating biomarkers and gene expression related
      to cancer progression, hormonal status, inflammation and other energy-related factors; b)
      rates of tumor proliferation and apoptosis; c) tumor markers, e.g., insulin receptor,
      Vascular Epithelial Growth Factor (VEGF), Nuclear Factor kappa beta (NFkB), and
      phosphoproteins associated with the Convergence of Hormones, Inflammation and Energy-Rated
      Factors (CHIEF) pathway; and d) functional and health-related outcomes. Because both tumor
      tissue and blood will be examined from pre-to-post-intervention, this study will provide
      exciting new data that can elucidate pathways by which energy balance affects breast cancer
      progression. Although longer term weight loss is recommended for overweight and obese breast
      cancer survivors, it is not known whether placing the body in a state of negative energy
      balance will have a favorable impact on the tumor. If beneficial changes in tumor biology and
      the host environment occur with short-term, pre-surgical weight loss, this study provides
      proof of concept that weight loss may offer an acceptable and complementary treatment option
      that could be combined with standard therapies.
Obesity is a known risk factor for invasive breast cancers that occur post-menopause. Obese
      women also die twice as frequently from breast cancer than those of normal weight. Numerous
      preclinical studies show the benefits of caloric restriction on cancer progression in animals
      - but, will similar effects be seen in humans? In response to a call for translational
      studies that will identify biological/biobehavioral pathways through which weight loss may
      affect cancer prognosis (PAR-12-229), the investigators propose a pilot study that builds on
      the investigators success of pre-surgical interventions to answer the research question,
      "does negative energy balance with concomitant weight loss invoke anti-cancer effects on
      tumor biology and the host environment?" The investigators will randomly assign 40 overweight
      or obese postmenopausal women diagnosed with ductal carcinoma in situ (DCIS) or early stage
      breast cancer who elect mastectomy or lumpectomy to 1-of-2 study arms: 1) an Attention
      Control Group that receives instruction on dietary approaches to correct nutritional
      deficiencies and progressive resistance training (PRT) that targets the arm ipsilateral to
      the affected breast; or 2) an Experimental Group that will receive PRT and guidance to
      correct nutritional deficiencies plus an intensive intervention to promote a 1.5-2 pound/week
      weight loss through diet, exercise, and behavior modification. This study will explore and
      contrast changes in body mass index (BMI) observed from enrollment to the time of surgery in
      the experimental vs. attention control arms, and also monitor changes in energy intake and
      physical activity. These changes will be studied in relation to the following endpoints: a)
      changes in select circulating biomarkers and gene expression related to cancer progression,
      hormonal status, inflammation and other energy-related factors; b) rates of tumor
      proliferation and apoptosis; c) tumor markers, e.g., insulin receptor, Vascular Epithelial
      Growth Factor (VEGF), Nuclear Factor kappa beta (NFkB), and phosphoproteins associated with
      the Convergence of Hormones, Inflammation and Energy-Rated Factors (CHIEF) pathway; and d)
      functional and health-related outcomes. Because both tumor tissue and blood will be examined
      from pre-to-post-intervention, this study will provide exciting new data that can elucidate
      pathways by which energy balance affects breast cancer progression from a non-invasive to an
      invasive state. Although longer term weight loss is recommended for overweight and obese
      breast cancer survivors, it is not known whether placing the body in a state of negative
      energy balance will have a favorable impact on the tumor. If beneficial changes in tumor
      biology and the host environment occur with short-term, pre-surgical weight loss, this study
      provides proof of concept that weight loss may offer an acceptable and complementary
      treatment option that could be combined with standard therapies. Thus, the research that is
      proposed will not only increase the investigators understanding of the impact of negative
      energy balance on tumor biology, but could change the standard of care and offer a more
      conservative treatment option for the 50,000 American women who are diagnosed with DCIS each
      year, as well as a novel adjunct therapy for women with early stage invasive disease.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Single (Outcomes Assessor)
measure: Tumor proliferation
time frame: Baseline to Time of Surgery
description: Ki-67 will be used to determine tumor proliferation. Ki-67 is a cancer antigen that is found in growing, dividing cells but is absent in the resting phase of cell growth. This characteristic makes Ki-67 a good tumor marker. This test is done on a sample of tumor tissue, to help predict prognosis. High levels of Ki-67 indicate an aggressive tumor and predict a poor prognosis. High scores mean that the cancer cells are growing and dividing at a rapid pace. The Ki-67 scores will be compared between arms.
measure: Weight
time frame: Baseline to Time of Surgery
measure: Feasibility
time frame: Baseline to Time of Surgery
description: Enroll 40 subjects within 2-year study, retain >80% of the sample and completion >70% of contact sessions.
measure: Body Composition
time frame: Baseline to Time of Surgery
description: Via Dual Energy Absorptiometry (DXA)
measure: Waist Circumference
time frame: Baseline to Time of Surgery
measure: Tumor markers
time frame: Baseline to Time of Surgery
description: Tumor Markers on the CHIEF (Convergence of Hormonal, Inflammatory and Energy-related Factors) Pathway, e.g., Insulin Receptor, Vascular Endothelial Growth Factor (VEGF), Tumor Necrosis Factor alpha (TNF-alpha), Nuclear Factor Kappa Beta (NFKB), caspase-3, as well as various phosphoproteins.
measure: Serum Biomarkers
time frame: Baseline to Time of Surgery
description: Insulin, leptin, Sex Hormone Binding Globulin, VEGF, TNF-alpha
measure: Gene expression
time frame: Baseline to Time of Surgery
description: Select genes on the CHIEF pathway as well as ~47,231 curated and putative genes and expressed sequence tags (ESTs)
measure: Dietary Intake
time frame: Baseline to Time of Surgery
description: 24-hour recalls to assess kcal intake as well as intake of fat, protein, and carbohydrate and diet quality
measure: Physical Activity
time frame: Baseline to Time of Surgery
description: Assessed via accelerometry as well as via questionnaire
measure: Quality of Life
time frame: Baseline to Time of Surgery
description: Using the FACT-B
measure: Cardiorespiratory Fitness
time frame: Baseline to Time of Surgery
description: Sub-maximal testing and a modified version of the Naughton Protocol
arm group label: Progressive Resistance Training (PRT) and a healthy diet
arm group type: Active Comparator
description: PRT will be done with resistance bands; participants will receive instruction on three resistance band exercises (triceps, biceps, and shoulder overhead) from an American College of Sports Medicine (ACSM) certified exercise specialist. Participants also will receive dietary counseling from a registered dietitian on correcting nutrient deficiencies that are detected during analysis of their 2-day dietary recalls.
arm group label: PRT and a healthy diet, plus weight loss
arm group type: Experimental
description: This arm will receive all components of the active comparator arm, plus counseling to achieve a weight loss of 1.5-2 pounds/week. Participants will be trained on how to achieve this caloric deficit through both dietary restriction and increased physical activity. Weight loss will be promoted via a healthy, nutritionally adequate diet consistent with American Cancer Society guidelines. Protein levels will be based on 0.8 g/kg body weight. The distribution of food groups will be customized for preferences. An exercise program will be tailored taking into account kcal expenditure for various activities at a specific body weight; expenditures of 200-400 kcal/day will serve as a goal. Aerobic training of large muscles (legs) will be emphasized to achieve a greater kcal deficit; ramping of intensity and volume over time will be pursued as per the ACSM guidelines. Participants will train once weekly while supervised by an exercise physiologist and daily at home.
intervention type: Behavioral
intervention name: Active Comparator: Progressive Resistance Training (PRT) and a healthy diet
description: no additional information; see arm description
arm group label: Progressive Resistance Training (PRT) and a healthy diet
other name: Diet; Exercise; Physical activity
intervention type: Behavioral
intervention name: Experimental: PRT and a healthy diet, plus weight loss
description: no additional information, see arm description
arm group label: PRT and a healthy diet, plus weight loss
other name: Diet; Exercise, Physical Activity
criteria: 
gender: Female
minimum age: 19 Years
maximum age: N/A
healthy volunteers: No
last name: Wendy Demark-Wahnefried, PhD, RD
role: Principal Investigator
affiliation: University of Alabama at Birmingham
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Alabama at Birmingham
investigator full name: Wendy Demark-Wahnefried, PhD
investigator title: Principal Investigator
mesh term: Carcinoma
mesh term: Carcinoma in Situ
mesh term: Carcinoma, Ductal
mesh term: Carcinoma, Intraductal, Noninfiltrating