<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/NCT04485767</url>
  </required_header>
  <id_info>
    <org_study_id>20-193</org_study_id>
    <secondary_id>R21AG065537</secondary_id>
    <nct_id>NCT04485767</nct_id>
  </id_info>
  <brief_title>RESIST-ADT (Androgen Deprivation Therapy)</brief_title>
  <official_title>Preventing a Decline in Physical Function in Older Androgen-Deprived Men With Structured Exercise Training (RESIST-ADT Trial)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Dana-Farber Cancer Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute on Aging (NIA)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Dana-Farber Cancer Institute</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 overall goal of this study is to determine if implementing structured exercises prevent&#xD;
      decline in muscle mass, muscle strength and physical function in men with prostate cancer&#xD;
      undergoing androgen deprivation therapy (ADT). Our main hypothesis is that structured&#xD;
      resistance exercise training in men undergoing ADT will preserve physical function assessed&#xD;
      by loaded stair climbing power compared with the control group. The trial will also examine&#xD;
      the efficacy of the exercise regimen on muscle strength, QOL and fatigue. The findings of&#xD;
      this trial will lay the groundwork for definitive intervention trials to prevent frailty and&#xD;
      falls in these men.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This randomized, controlled, parallel group trial of 6-months duration is determining the&#xD;
      efficacy of structured resistance exercise training in preventing the decline in physical&#xD;
      function in older men with prostate cancer undergoing androgen deprivation therapy (ADT). It&#xD;
      will compare the structured resistance exercise training with a control group of men&#xD;
      undergoing flexibility and balance exercises training.&#xD;
&#xD;
      Men undergoing ADT for treatment of their prostate cancer experience a significant decline in&#xD;
      muscle mass and muscle strength, which impacts their physical function. This predisposes them&#xD;
      to frailty and a higher risk of falls. In addition to physical dysfunction, men undergoing&#xD;
      ADT also experience a significant decrease in health-related quality of life and experience&#xD;
      fatigue (tiredness).&#xD;
&#xD;
      This research study is taking a preventative approach to the physical function problems in&#xD;
      men with prostate cancer by implementing exercise interventions before participants begin ADT&#xD;
      that are specifically designed to improve muscle mass, muscle strength and physical function&#xD;
      to lessen the impacts of muscle mass and strength decline.&#xD;
&#xD;
      The study includes a screening visit during which the following procedures will be conducted:&#xD;
      Vitals, EKG, blood sample collection and a physical to determine eligibility. If qualified,&#xD;
      participants will be randomly assigned to two different types of structured exercises:&#xD;
      Resistance exercise training or flexibility and balance exercises. During the weekly exercise&#xD;
      training 20 subjects will be assigned to the Exercise A group and 20 subjects to the Exercise&#xD;
      B group. The exercise training sessions will occur approximately 2 times/week. In addition&#xD;
      participants will also undergo DEXA scans, perform muscle strength testing and complete&#xD;
      questionnaires at baseline, 3- and 6-month visits.&#xD;
&#xD;
      It is expected participants will be in this research study for up to 6 months. It is expected&#xD;
      that about 40 people will take part in this research study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">December 1, 2020</start_date>
  <completion_date type="Anticipated">October 31, 2024</completion_date>
  <primary_completion_date type="Anticipated">July 31, 2024</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>
    <intervention_model_description>Structured Resistance Exercise vs Control Exercise</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
    <masking_description>Participants, Investigators and Research Staff will remain blinded.&#xD;
Only exercise personnel and study statistician will be unblinded.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Loaded stair climb power</measure>
    <time_frame>6 months</time_frame>
    <description>Compare the efficacy of a structured resistance exercise regimen vs a structured control regimen on loaded stair climb power. Assessment of physical function as measured by Loaded Stair Climbing Power.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Body composition</measure>
    <time_frame>6 months</time_frame>
    <description>Lean body mass measured by dual energy x-ray absorptiometry (DEXA)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Muscle strength and power</measure>
    <time_frame>6 months</time_frame>
    <description>Maximal voluntary muscle strength in the lower extremities will be assessed by conducting the leg and chest press exercise by the 1-repetition maximum method and assessing loaded stair climb power.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of Life (QOL)</measure>
    <time_frame>6 months</time_frame>
    <description>Measured by SF-36 questionnaire a multi-purpose survey designed to capture adult patients' perceptions of their own health and well-being</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fatigue</measure>
    <time_frame>6 months</time_frame>
    <description>Fatigue will be assessed by the Functional Assessment of Chronic Illness Therapy fatigue scale (FACIT-F).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Prostate Cancer</condition>
  <condition>Physical Function</condition>
  <arm_group>
    <arm_group_label>Progressive Resistance Training Exercise</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Men with prostate cancer who are about to begin androgen-deprivation therapy (ADT) will attend structured progressive resistance exercise training sessions 2 times/week for six months.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Flexibility and Balance Exercise</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Men with prostate cancer who are about to begin androgen-deprivation therapy (ADT) will attend flexibility and balance exercises training sessions 2 times/week for six months.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Progressive Resistance Training Exercise</intervention_name>
    <description>Progressive Resistance Training Exercise 2x weekly for 6 months.</description>
    <arm_group_label>Progressive Resistance Training Exercise</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Flexibility and Balance Exercise</intervention_name>
    <description>Flexibility and Balance Exercise Training Exercise 2x weekly for 6 months.</description>
    <arm_group_label>Flexibility and Balance Exercise</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Men with active Prostate Cancer who are 60 years or older.&#xD;
&#xD;
          -  Hormone-naive men about to undergo medical or surgical ADT.&#xD;
&#xD;
          -  Planned ADT for at least 6 months.&#xD;
&#xD;
          -  Life expectancy of at least 6 months from enrollment.&#xD;
&#xD;
          -  Ability and willingness to provide informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Active medical conditions affecting participation in exercise training (limiting&#xD;
             arthropathies, myopathies, severe peripheral vascular disease, or severe neuropathy).&#xD;
&#xD;
          -  Cardiovascular disease (current angina, severe valvular disease, advanced congestive&#xD;
             heart failure, arrhythmias, or stroke with residual muscular weakness).&#xD;
&#xD;
          -  Prior hip or knee replacement.&#xD;
&#xD;
          -  History of lower extremity fracture in the past 6 months.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Shehzad Basaria, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Brigham and Women's Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Thomas Storer, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Brigham and Women's Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Shehzad Basaria, MD</last_name>
    <phone>617-525-9144</phone>
    <email>sbasaria@bwh.harvard.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Milena Braga, MD</last_name>
    <phone>617-525-9144</phone>
    <email>mbraga2@bwh.harvard.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Dana-Farber Cancer Institute</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02066</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Shehzad Basaria, MD</last_name>
      <phone>617-525-9144</phone>
      <email>sbasaria@bwh.harvard.edu</email>
    </contact>
    <contact_backup>
      <last_name>Milena Braga, MD</last_name>
      <phone>617-525-9144</phone>
      <email>mbraga2@bwh.harvard.edu</email>
    </contact_backup>
    <investigator>
      <last_name>Shehzad Basaria, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Thomas Storer, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Brigham and Women's Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02115</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Shehzad Basaria, MD</last_name>
      <phone>617-525-9144</phone>
      <email>sbasaria@bwh.harvard.edu</email>
    </contact>
    <contact_backup>
      <last_name>Milena Braga, MD</last_name>
      <phone>617-525-9144</phone>
      <email>mbraga2@bwh.harvard.edu</email>
    </contact_backup>
    <investigator>
      <last_name>Shehzad Basaria, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Thomas Storer, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>July 22, 2020</study_first_submitted>
  <study_first_submitted_qc>July 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 24, 2020</study_first_posted>
  <last_update_submitted>August 14, 2023</last_update_submitted>
  <last_update_submitted_qc>August 14, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 15, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Dana-Farber Cancer Institute</investigator_affiliation>
    <investigator_full_name>Shehzad Basaria, MD</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Prostate Cancer</keyword>
  <keyword>Androgen Deprivation Therapy (ADT)</keyword>
  <keyword>Physical Function</keyword>
  <keyword>Structured Exercise</keyword>
  <keyword>Muscle Strength and Power</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prostatic Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_time_frame>Data can be shared no earlier than 1 year following the date of publication</ipd_time_frame>
    <ipd_access_criteria>BWH - Contact the Partners Innovations team at http://www.partners.org/innovation DFCI - Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu</ipd_access_criteria>
  </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/NCT04485767
org study id: 20-193
secondary id: R21AG065537
nct id: NCT04485767
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The overall goal of this study is to determine if implementing structured exercises prevent
      decline in muscle mass, muscle strength and physical function in men with prostate cancer
      undergoing androgen deprivation therapy (ADT). Our main hypothesis is that structured
      resistance exercise training in men undergoing ADT will preserve physical function assessed
      by loaded stair climbing power compared with the control group. The trial will also examine
      the efficacy of the exercise regimen on muscle strength, QOL and fatigue. The findings of
      this trial will lay the groundwork for definitive intervention trials to prevent frailty and
      falls in these men.
This randomized, controlled, parallel group trial of 6-months duration is determining the
      efficacy of structured resistance exercise training in preventing the decline in physical
      function in older men with prostate cancer undergoing androgen deprivation therapy (ADT). It
      will compare the structured resistance exercise training with a control group of men
      undergoing flexibility and balance exercises training.

      Men undergoing ADT for treatment of their prostate cancer experience a significant decline in
      muscle mass and muscle strength, which impacts their physical function. This predisposes them
      to frailty and a higher risk of falls. In addition to physical dysfunction, men undergoing
      ADT also experience a significant decrease in health-related quality of life and experience
      fatigue (tiredness).

      This research study is taking a preventative approach to the physical function problems in
      men with prostate cancer by implementing exercise interventions before participants begin ADT
      that are specifically designed to improve muscle mass, muscle strength and physical function
      to lessen the impacts of muscle mass and strength decline.

      The study includes a screening visit during which the following procedures will be conducted:
      Vitals, EKG, blood sample collection and a physical to determine eligibility. If qualified,
      participants will be randomly assigned to two different types of structured exercises:
      Resistance exercise training or flexibility and balance exercises. During the weekly exercise
      training 20 subjects will be assigned to the Exercise A group and 20 subjects to the Exercise
      B group. The exercise training sessions will occur approximately 2 times/week. In addition
      participants will also undergo DEXA scans, perform muscle strength testing and complete
      questionnaires at baseline, 3- and 6-month visits.

      It is expected participants will be in this research study for up to 6 months. It is expected
      that about 40 people will take part in this research study.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Structured Resistance Exercise vs Control Exercise
primary purpose: Supportive Care
masking: Double (Participant, Investigator)
masking description: Participants, Investigators and Research Staff will remain blinded.
Only exercise personnel and study statistician will be unblinded.
measure: Loaded stair climb power
time frame: 6 months
description: Compare the efficacy of a structured resistance exercise regimen vs a structured control regimen on loaded stair climb power. Assessment of physical function as measured by Loaded Stair Climbing Power.
measure: Body composition
time frame: 6 months
description: Lean body mass measured by dual energy x-ray absorptiometry (DEXA)
measure: Muscle strength and power
time frame: 6 months
description: Maximal voluntary muscle strength in the lower extremities will be assessed by conducting the leg and chest press exercise by the 1-repetition maximum method and assessing loaded stair climb power.
measure: Quality of Life (QOL)
time frame: 6 months
description: Measured by SF-36 questionnaire a multi-purpose survey designed to capture adult patients' perceptions of their own health and well-being
measure: Fatigue
time frame: 6 months
description: Fatigue will be assessed by the Functional Assessment of Chronic Illness Therapy fatigue scale (FACIT-F).
arm group label: Progressive Resistance Training Exercise
arm group type: Experimental
description: Men with prostate cancer who are about to begin androgen-deprivation therapy (ADT) will attend structured progressive resistance exercise training sessions 2 times/week for six months.
arm group label: Flexibility and Balance Exercise
arm group type: Active Comparator
description: Men with prostate cancer who are about to begin androgen-deprivation therapy (ADT) will attend flexibility and balance exercises training sessions 2 times/week for six months.
intervention type: Behavioral
intervention name: Progressive Resistance Training Exercise
description: Progressive Resistance Training Exercise 2x weekly for 6 months.
arm group label: Progressive Resistance Training Exercise
intervention type: Behavioral
intervention name: Flexibility and Balance Exercise
description: Flexibility and Balance Exercise Training Exercise 2x weekly for 6 months.
arm group label: Flexibility and Balance Exercise
criteria: 
gender: Male
gender based: Yes
minimum age: 60 Years
maximum age: N/A
healthy volunteers: No
last name: Shehzad Basaria, MD
role: Principal Investigator
affiliation: Brigham and Women's Hospital
last name: Thomas Storer, PhD
role: Principal Investigator
affiliation: Brigham and Women's Hospital
last name: Shehzad Basaria, MD
phone: 617-525-9144
email: sbasaria@bwh.harvard.edu
last name: Milena Braga, MD
phone: 617-525-9144
email: mbraga2@bwh.harvard.edu
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Dana-Farber Cancer Institute
investigator full name: Shehzad Basaria, MD
investigator title: Principal Investigator
mesh term: Prostatic Neoplasms
sharing ipd: Yes
ipd description: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd time frame: Data can be shared no earlier than 1 year following the date of publication
ipd access criteria: BWH - Contact the Partners Innovations team at http://www.partners.org/innovation DFCI - Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu