<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/NCT02248350</url>
  </required_header>
  <id_info>
    <org_study_id>Georgetown_University_MC</org_study_id>
    <nct_id>NCT02248350</nct_id>
  </id_info>
  <brief_title>An Exercise Intervention for Prostate Cancer Patients Receiving Androgen Deprivation Therapy</brief_title>
  <acronym>MIGHTY</acronym>
  <official_title>An Exercise Intervention to Mitigate Side-Effects Related to Androgen Deprivation Therapy Among Prostate Cancer Survivors.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Georgetown University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>American Cancer Society, Inc.</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Georgetown University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This main purpose of this study is to examine the effects of an exercise intervention to&#xD;
      counteract adverse side effects related to Androgen Deprivation Therapy (ADT) in prostate&#xD;
      cancer patients. Specifically, a supervised and home-based exercise program will be used to&#xD;
      assess its impact on clinical and behavioral variables related to ADT in prostate cancer&#xD;
      patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study will assess the feasibility of an exercise intervention to counteract adverse side&#xD;
      effects related to ADT in prostate cancer (PCa) patients. Specifically, we will use an&#xD;
      exercise intervention and assess its impact on bone mass density, Body Mass Index (BMI),&#xD;
      hip/waist circumference levels, biomarkers (i.e., glucose, lipids), step count, grip&#xD;
      strength, and health-related quality of life (HRQOL) using the Patient Reported Outcomes&#xD;
      Measurement Information System (PROMIS®). In this 8-week two-arm randomized clinical trial,&#xD;
      40 PCa patients receiving ADT will be randomly assigned to an exercise (n=20) or a stretching&#xD;
      control group (n=20) with a follow-up at 8-weeks.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">September 2017</completion_date>
  <primary_completion_date type="Actual">September 2017</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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Bone Mineral Density</measure>
    <time_frame>8-weeks</time_frame>
    <description>BMD will be measured by a DXA scan</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Physical Fitness</measure>
    <time_frame>8-weeks</time_frame>
    <description>. The Bruce treadmill protocol will be used to examine VO2max using a ParvoMedics TrueOne 2400 metabolic cart</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Muscle strength</measure>
    <time_frame>8-weeks</time_frame>
    <description>Grip strength will be measured in a standardized way (three times in each arm) using a Jamar Dynamometer</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Step Count</measure>
    <time_frame>8-weeks</time_frame>
    <description>The Fit Bit reliably measures daily steps taken, distance walked, calories burned, and overall activity level.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of Life (HRQOL)</measure>
    <time_frame>8-weeks</time_frame>
    <description>The 10-item PROMIS® Global Health Scale will be used to assess key HRQOL domains including pain, fatigue, mental health, physical health, social health, and overall health</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hip/Waist Circumference</measure>
    <time_frame>8-weeks</time_frame>
    <description>Anthropometric measures</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body Mass Index (BMI)</measure>
    <time_frame>8-weeks</time_frame>
    <description>BMI will be measured according to height and weight</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Glucose/Lipid levels</measure>
    <time_frame>8-weeks</time_frame>
    <description>A fasting finger stick sample of blood (35 μl) will be assessed for immediate analysis of lipid panel (i.e., total cholesterol, HDL cholesterol, LDL cholesterol, VLDL cholesterol, triglycerides) and fasting glucose</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">19</enrollment>
  <condition>Prostate Cancer</condition>
  <condition>Physical Activity</condition>
  <condition>Side-effects</condition>
  <arm_group>
    <arm_group_label>Exercise Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>8-weeks of supervised and home based exercise intervention, 3 times a week, 50-minutes a session for a total of 150/minutes a week</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Stretching Control group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Informational booklet containing stretching exercises (20-minutes a day)</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Supervised and Home Based Exercise</intervention_name>
    <description>Participants will come to our community based research office for up to 50 min/session, 3-days/week of supervised exercise for 8-weeks. The exercise intensity will be tailored between 60-80% of their VO2max, as determined during baseline testing and with a rating of perceived exertion (RPE) of 11-14 on the 20-point scale.</description>
    <arm_group_label>Exercise Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Stretching Control Group</intervention_name>
    <description>Participants randomized into the control group will be provided an informational booklet with stretching techniques and exercises and will be asked to stretch at least 20-minutes a day for the duration of the study.</description>
    <arm_group_label>Stretching Control group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  (1) Caucasian or African-American/Black men; (2) histologically confirmed&#xD;
             non-metastatic PCa; (3) receiving ADT treatment for 9-months or less upon recruitment&#xD;
             (and continue to receive treatment during the duration of the study); (4) 40 to 75&#xD;
             years old; (5) sedentary defined as &lt;60 minutes of recreation or work requiring modest&#xD;
             PA/week; (6) ability to perform the level of physical activity assessed by the&#xD;
             Physical Activity Readiness Questionnaire (PAR-Q); (6) has access to a smartphone or&#xD;
             computer with internet capabilities&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  (1) severe cardiac disease; (2) recent myocardial infarction; (3) treated for any&#xD;
             other cancer; (4) any physical, psychological illness, and/or medical problems that&#xD;
             restricted them from exercise; (5) and not willing or able to follow procedures&#xD;
             specified by the study and/or instructions of the researcher.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Office of Minority Health and Health Disparities Research</name>
      <address>
        <city>Washington</city>
        <state>District of Columbia</state>
        <zip>20003</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2016</verification_date>
  <study_first_submitted>September 22, 2014</study_first_submitted>
  <study_first_submitted_qc>September 22, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 25, 2014</study_first_posted>
  <last_update_submitted>February 13, 2018</last_update_submitted>
  <last_update_submitted_qc>February 13, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">February 15, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>prostate cancer</keyword>
  <keyword>physical activity</keyword>
  <keyword>exercise</keyword>
  <keyword>intervention</keyword>
  <keyword>side effects</keyword>
  <keyword>androgen deprivation therapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prostatic Neoplasms</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/NCT02248350
org study id: Georgetown_University_MC
nct id: NCT02248350
lead sponsor: 
collaborator: 
has dmc: Yes
This main purpose of this study is to examine the effects of an exercise intervention to
      counteract adverse side effects related to Androgen Deprivation Therapy (ADT) in prostate
      cancer patients. Specifically, a supervised and home-based exercise program will be used to
      assess its impact on clinical and behavioral variables related to ADT in prostate cancer
      patients.
This study will assess the feasibility of an exercise intervention to counteract adverse side
      effects related to ADT in prostate cancer (PCa) patients. Specifically, we will use an
      exercise intervention and assess its impact on bone mass density, Body Mass Index (BMI),
      hip/waist circumference levels, biomarkers (i.e., glucose, lipids), step count, grip
      strength, and health-related quality of life (HRQOL) using the Patient Reported Outcomes
      Measurement Information System (PROMIS®). In this 8-week two-arm randomized clinical trial,
      40 PCa patients receiving ADT will be randomly assigned to an exercise (n=20) or a stretching
      control group (n=20) with a follow-up at 8-weeks.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Double (Participant, Investigator)
measure: Bone Mineral Density
time frame: 8-weeks
description: BMD will be measured by a DXA scan
measure: Physical Fitness
time frame: 8-weeks
description: . The Bruce treadmill protocol will be used to examine VO2max using a ParvoMedics TrueOne 2400 metabolic cart
measure: Muscle strength
time frame: 8-weeks
description: Grip strength will be measured in a standardized way (three times in each arm) using a Jamar Dynamometer
measure: Step Count
time frame: 8-weeks
description: The Fit Bit reliably measures daily steps taken, distance walked, calories burned, and overall activity level.
measure: Quality of Life (HRQOL)
time frame: 8-weeks
description: The 10-item PROMIS® Global Health Scale will be used to assess key HRQOL domains including pain, fatigue, mental health, physical health, social health, and overall health
measure: Hip/Waist Circumference
time frame: 8-weeks
description: Anthropometric measures
measure: Body Mass Index (BMI)
time frame: 8-weeks
description: BMI will be measured according to height and weight
measure: Glucose/Lipid levels
time frame: 8-weeks
description: A fasting finger stick sample of blood (35 μl) will be assessed for immediate analysis of lipid panel (i.e., total cholesterol, HDL cholesterol, LDL cholesterol, VLDL cholesterol, triglycerides) and fasting glucose
arm group label: Exercise Group
arm group type: Experimental
description: 8-weeks of supervised and home based exercise intervention, 3 times a week, 50-minutes a session for a total of 150/minutes a week
arm group label: Stretching Control group
arm group type: Active Comparator
description: Informational booklet containing stretching exercises (20-minutes a day)
intervention type: Behavioral
intervention name: Supervised and Home Based Exercise
description: Participants will come to our community based research office for up to 50 min/session, 3-days/week of supervised exercise for 8-weeks. The exercise intensity will be tailored between 60-80% of their VO2max, as determined during baseline testing and with a rating of perceived exertion (RPE) of 11-14 on the 20-point scale.
arm group label: Exercise Group
intervention type: Behavioral
intervention name: Stretching Control Group
description: Participants randomized into the control group will be provided an informational booklet with stretching techniques and exercises and will be asked to stretch at least 20-minutes a day for the duration of the study.
arm group label: Stretching Control group
criteria: 
gender: Male
minimum age: 40 Years
maximum age: 70 Years
healthy volunteers: No
facility: 
country: United States
responsible party type: Sponsor
mesh term: Prostatic Neoplasms