<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/NCT04472286</url>
  </required_header>
  <id_info>
    <org_study_id>0206-20-FB</org_study_id>
    <nct_id>NCT04472286</nct_id>
  </id_info>
  <brief_title>Healthy Bones, Healthy Life: Habitual Physical Activity on Bone &amp; Metabolic Health in Pediatric Cancer Survivors</brief_title>
  <acronym>HBHL</acronym>
  <official_title>Healthy Bones, Healthy Life: Effect of Habitual Physical Activity on Bone and Metabolic Health in Pediatric Cancer Survivors</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Nebraska</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Nebraska</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 project will examine habitual physical activity, bone health, and insulin resistance in&#xD;
      pediatric acute lymphocytic leukemia (ALL) and lymphoma cancer survivors at two time points:&#xD;
      baseline and 6 months. At the two study timepoints, all study participants will be asked to&#xD;
      wear an accelerometer, receive a DXA scan of the lumbar spine and hip, and have blood drawn&#xD;
      for analysis. Study participants will be given a gift card stipend for each study visit&#xD;
      attended. Study visits will coincide with regular office visits to Children's Hospital&#xD;
      Oncology Clinic and the Children's Hospital Survivorship Clinics whenever possible. The&#xD;
      potential mechanism by which physical activity mediates bone changes will be explored by&#xD;
      concurrently measuring changes in lean/fat mass and metabolic status. This pilot study will&#xD;
      provide data to inform the design of a randomized controlled trial to test the effect of a&#xD;
      physical activity intervention on bone health in PCS.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Childhood cancer treatments are increasingly effective, leading to dramatic improvements in&#xD;
      survival rates. These treatments often have devastating effects on the overall health of&#xD;
      pediatric cancer survivors (PCS) since they occur during a critical time of bone growth,&#xD;
      including increased risks of poor bone health, fracture, and diabetes. In normal child&#xD;
      development, physical activity habits influence bone density and structure, which affect bone&#xD;
      strength in adulthood. Despite this well-understood principle of bone development, there are&#xD;
      no exercise guidelines for improving bone health in PCS. The long-term goal of this research&#xD;
      is to develop an effective exercise intervention to improve bone health after cancer therapy.&#xD;
      As a first step, the investigators propose to test the hypothesis that the intensity and&#xD;
      amount of ground impact of a child's daily physical activity will influence changes in bone&#xD;
      density in PCS. The Specific Aims are to (1) examine the effect of physical activity on&#xD;
      lumbar bone density of PCS and to (2) evaluate how physical activity influences bone density.&#xD;
      In a prospective cohort study, the investigators will enroll 38 pediatric and adolescent&#xD;
      survivors (ages 5-18) of acute lymphoblastic leukemia or lymphoma at any post-treatment time&#xD;
      point. Aim 1: At two assessments, baseline and six months later, bone density and structure&#xD;
      (by DXA scan, a type of x-ray that can measure bone density and the amount of muscle and fat&#xD;
      in the body) and physical activity level (by accelerometry, a device like a fitness tracker)&#xD;
      will be evaluated. Each child will be categorized as having low or high physical activity&#xD;
      based on accelerometry measures averaged from baseline and six-month assessments. Bone&#xD;
      changes (0-6 months) will be compared between low and high activity groups. Aim 2: Evaluate&#xD;
      potential mechanisms by which physical activity mediates changes in bone, including the&#xD;
      effects of lean mass (measured by DXA) and metabolic health (lipid panel, insulin sensitivity&#xD;
      (HOMA-IR, hemoglobin A1c), vitamin D). Long-term impact: This research will provide&#xD;
      information as to the types of exercise that impact bone health in PCS. This study will help&#xD;
      develop effective, evidence-based exercise therapies. These therapies may help prevent&#xD;
      fractures and associated disability, leading to an improvement in the quality of life for&#xD;
      survivors of pediatric cancer.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">November 1, 2020</start_date>
  <completion_date type="Anticipated">January 30, 2024</completion_date>
  <primary_completion_date type="Anticipated">October 30, 2023</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Bone Mineral Density (g/cm2)</measure>
    <time_frame>6 months</time_frame>
    <description>z-score of lumbar Spine bone density- DXA scan</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Hip structural analysis</measure>
    <time_frame>6 months</time_frame>
    <description>DXA scan</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Physical Activity Level</measure>
    <time_frame>6 months</time_frame>
    <description>Physical Activity as measured by accelerometry</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Lipid panel</measure>
    <time_frame>6 months</time_frame>
    <description>cholesterol (total, HDL, and LDL) and triglycerides will be measured, which are an indicator of overall cardiovascular health which can impact insulin sensitivity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Homeostatic Model Assessment for Insulin Resistance</measure>
    <time_frame>6 months</time_frame>
    <description>Fasting Insulin and Fasting Glucose will be combined to calculate the HOMA-IR, which is an indicator of insulin sensitivity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hemoglobin A1c</measure>
    <time_frame>6 months</time_frame>
    <description>measure of the glycated hemoglobin in blood, which is an indicator of insulin sensitivity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vitamin D</measure>
    <time_frame>6 months</time_frame>
    <description>measures the levels of vitamin D in the blood which is an indicator of bone health</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Acute Lymphoblastic Leukemia, Pediatric</condition>
  <condition>Pediatric ALL</condition>
  <condition>Pediatric Lymphoma</condition>
  <condition>Bone Loss</condition>
  <condition>Metabolic Syndrome</condition>
  <condition>Habitual Physical Activity</condition>
  <condition>Precursor Cell Lymphoblastic Leukemia</condition>
  <condition>Lymphoma</condition>
  <condition>Leukemia</condition>
  <condition>Lymphoid Leukemia</condition>
  <condition>Pediatric</condition>
  <condition>Osteoporosis</condition>
  <condition>Osteoporosis Risk</condition>
  <arm_group>
    <arm_group_label>Pediatric Cancer Survivors</arm_group_label>
    <description>Children and adolescents who have completed treatment of for acute lymphoblastic leukemia (ALL) and lymphoma.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Pediatric cancer survivors who are in the first year after treatment completion&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Children between the ages of 5-18&#xD;
&#xD;
          2. Diagnosis of ALL or Lymphoma&#xD;
&#xD;
          3. Between 1-13 months post-cancer treatment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Children younger than 5 years old or 19 or older&#xD;
&#xD;
          2. Children without a diagnosis of ALL or lymphoma&#xD;
&#xD;
          3. Children receiving ongoing cancer treatment&#xD;
&#xD;
          4. Children with Down syndrome (identified as a precancerous condition affecting BMD)&#xD;
&#xD;
          5. Children with a prior history of bisphosphonate use or other medication directed at&#xD;
             increasing bone density&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>5 Years</minimum_age>
    <maximum_age>18 Years</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Laura D Bilek, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Nebraska</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Laura D Bilek, PhD</last_name>
    <phone>402-559-6923</phone>
    <email>lbilek@unmc.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>University of Nebraska Medical Center</name>
      <address>
        <city>Omaha</city>
        <state>Nebraska</state>
        <zip>68198</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Laura D Bilek, PhD</last_name>
      <phone>402-559-6463</phone>
      <email>lbilek@unmc.edu</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2023</verification_date>
  <study_first_submitted>July 10, 2020</study_first_submitted>
  <study_first_submitted_qc>July 10, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 15, 2020</study_first_posted>
  <last_update_submitted>September 8, 2023</last_update_submitted>
  <last_update_submitted_qc>September 8, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 13, 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>Lymphoma</mesh_term>
    <mesh_term>Leukemia</mesh_term>
    <mesh_term>Precursor Cell Lymphoblastic Leukemia-Lymphoma</mesh_term>
    <mesh_term>Leukemia, Lymphoid</mesh_term>
    <mesh_term>Osteoporosis</mesh_term>
    <mesh_term>Metabolic Syndrome</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/NCT04472286
org study id: 0206-20-FB
nct id: NCT04472286
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This project will examine habitual physical activity, bone health, and insulin resistance in
      pediatric acute lymphocytic leukemia (ALL) and lymphoma cancer survivors at two time points:
      baseline and 6 months. At the two study timepoints, all study participants will be asked to
      wear an accelerometer, receive a DXA scan of the lumbar spine and hip, and have blood drawn
      for analysis. Study participants will be given a gift card stipend for each study visit
      attended. Study visits will coincide with regular office visits to Children's Hospital
      Oncology Clinic and the Children's Hospital Survivorship Clinics whenever possible. The
      potential mechanism by which physical activity mediates bone changes will be explored by
      concurrently measuring changes in lean/fat mass and metabolic status. This pilot study will
      provide data to inform the design of a randomized controlled trial to test the effect of a
      physical activity intervention on bone health in PCS.
Childhood cancer treatments are increasingly effective, leading to dramatic improvements in
      survival rates. These treatments often have devastating effects on the overall health of
      pediatric cancer survivors (PCS) since they occur during a critical time of bone growth,
      including increased risks of poor bone health, fracture, and diabetes. In normal child
      development, physical activity habits influence bone density and structure, which affect bone
      strength in adulthood. Despite this well-understood principle of bone development, there are
      no exercise guidelines for improving bone health in PCS. The long-term goal of this research
      is to develop an effective exercise intervention to improve bone health after cancer therapy.
      As a first step, the investigators propose to test the hypothesis that the intensity and
      amount of ground impact of a child's daily physical activity will influence changes in bone
      density in PCS. The Specific Aims are to (1) examine the effect of physical activity on
      lumbar bone density of PCS and to (2) evaluate how physical activity influences bone density.
      In a prospective cohort study, the investigators will enroll 38 pediatric and adolescent
      survivors (ages 5-18) of acute lymphoblastic leukemia or lymphoma at any post-treatment time
      point. Aim 1: At two assessments, baseline and six months later, bone density and structure
      (by DXA scan, a type of x-ray that can measure bone density and the amount of muscle and fat
      in the body) and physical activity level (by accelerometry, a device like a fitness tracker)
      will be evaluated. Each child will be categorized as having low or high physical activity
      based on accelerometry measures averaged from baseline and six-month assessments. Bone
      changes (0-6 months) will be compared between low and high activity groups. Aim 2: Evaluate
      potential mechanisms by which physical activity mediates changes in bone, including the
      effects of lean mass (measured by DXA) and metabolic health (lipid panel, insulin sensitivity
      (HOMA-IR, hemoglobin A1c), vitamin D). Long-term impact: This research will provide
      information as to the types of exercise that impact bone health in PCS. This study will help
      develop effective, evidence-based exercise therapies. These therapies may help prevent
      fractures and associated disability, leading to an improvement in the quality of life for
      survivors of pediatric cancer.
observational model: Cohort
time perspective: Prospective
measure: Bone Mineral Density (g/cm2)
time frame: 6 months
description: z-score of lumbar Spine bone density- DXA scan
measure: Hip structural analysis
time frame: 6 months
description: DXA scan
measure: Physical Activity Level
time frame: 6 months
description: Physical Activity as measured by accelerometry
measure: Lipid panel
time frame: 6 months
description: cholesterol (total, HDL, and LDL) and triglycerides will be measured, which are an indicator of overall cardiovascular health which can impact insulin sensitivity
measure: Homeostatic Model Assessment for Insulin Resistance
time frame: 6 months
description: Fasting Insulin and Fasting Glucose will be combined to calculate the HOMA-IR, which is an indicator of insulin sensitivity
measure: Hemoglobin A1c
time frame: 6 months
description: measure of the glycated hemoglobin in blood, which is an indicator of insulin sensitivity
measure: Vitamin D
time frame: 6 months
description: measures the levels of vitamin D in the blood which is an indicator of bone health
arm group label: Pediatric Cancer Survivors
description: Children and adolescents who have completed treatment of for acute lymphoblastic leukemia (ALL) and lymphoma.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 5 Years
maximum age: 18 Years
last name: Laura D Bilek, PhD
role: Principal Investigator
affiliation: University of Nebraska
last name: Laura D Bilek, PhD
phone: 402-559-6923
email: lbilek@unmc.edu
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Sponsor
mesh term: Lymphoma
mesh term: Leukemia
mesh term: Precursor Cell Lymphoblastic Leukemia-Lymphoma
mesh term: Leukemia, Lymphoid
mesh term: Osteoporosis
mesh term: Metabolic Syndrome
sharing ipd: No