<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/NCT03261271</url>
  </required_header>
  <id_info>
    <org_study_id>STUDY00141060</org_study_id>
    <secondary_id>RSG-17-050-01-NEC</secondary_id>
    <nct_id>NCT03261271</nct_id>
  </id_info>
  <brief_title>Weight Management Aimed to Reduce Risk and Improve Outcomes From Radical Prostatectomy</brief_title>
  <acronym>WARRIOR</acronym>
  <official_title>Weight Management Aimed to Reduce Risk and Improve Outcomes From Radical Prostatectomy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Kansas Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>American Cancer Society, Inc.</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </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 study is to test how a weight management program affects substances in&#xD;
      the blood called biomarkers that can show the presence or severity of cancer, compared to a&#xD;
      standardized diet and exercise educational flyer.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">August 28, 2017</start_date>
  <completion_date type="Anticipated">September 2021</completion_date>
  <primary_completion_date type="Anticipated">September 2021</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>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Impact of weight loss before and weight maintenance after Prostate Cancer (PCa) surgery on immunosuppressive factors</measure>
    <time_frame>Change from Baseline to Month 6</time_frame>
    <description>Impact will be measured by changes in specific blood immune biomarker biomarkers.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Impact of weight loss before and weight maintenance after PCa surgery on inflammation factors</measure>
    <time_frame>Change from Baseline to Month 6</time_frame>
    <description>Impact will be measured by changes in specific blood inflammation biomarkers.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in weight</measure>
    <time_frame>Change from Baseline to Month 6</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in body composition</measure>
    <time_frame>Change from Baseline to Prior to Surgery, from 4 to 16 weeks</time_frame>
    <description>Body composition will be measured using a Dual Energy X-Ray Absorptiometry (iDXA).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Quality of Life</measure>
    <time_frame>Change from Baseline to Month 6</time_frame>
    <description>Quality of Life will be measured using the Expanded PCa Index Composite (EPIC) Instrument-26. There are a total of 26 items on the survey. Scores range from 0 to 100. The higher the score, the higher the quality of life.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Obesity</condition>
  <condition>Prostate Cancer</condition>
  <arm_group>
    <arm_group_label>Weight Loss and Weight Maintenance</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will take part in a weight loss program for at least 4 weeks (and up to 16 weeks) before their prostatectomy, and a weight maintenance program for 6 months after their surgery.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants will receive a standardized educational flyer about a healthy diet and exercise.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Weight Loss Program</intervention_name>
    <description>Program involves one-on-one coaching, diet meal plan, and physical activity plan.</description>
    <arm_group_label>Weight Loss and Weight Maintenance</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Standardized educational flyer</intervention_name>
    <description>The American Institute for Cancer Research handout &quot;Nutrition and the Cancer Survivor&quot; will be provided to participants.</description>
    <arm_group_label>Control</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Weight Maintenance Program</intervention_name>
    <description>Post-surgery program involves group support sessions, phone check-ins, and diet and exercise monitoring.</description>
    <arm_group_label>Weight Loss and Weight Maintenance</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Men newly diagnosed with PCa who are scheduled for radical prostatectomy (RP) (T1 or&#xD;
             T2)&#xD;
&#xD;
          -  Body Mass Index (BMI) 25-45 kg/m2&#xD;
&#xD;
          -  Has internet access&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of 5 alpha reductase inhibitors prior 3 months&#xD;
&#xD;
          -  History of radiation therapy for cancer treatment&#xD;
&#xD;
          -  Taking active cancer treatment&#xD;
&#xD;
          -  Undergoing salvage therapy&#xD;
&#xD;
          -  Castration-resistant PCa&#xD;
&#xD;
          -  Evidence of metastasis&#xD;
&#xD;
          -  Evidence of biochemical recurrence&#xD;
&#xD;
          -  High risk medical condition (e.g. kidney disease, uncontrolled diabetes, etc.)&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jill Hamilton-Reeves, PhD</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>
  <verification_date>September 2020</verification_date>
  <study_first_submitted>August 22, 2017</study_first_submitted>
  <study_first_submitted_qc>August 22, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 24, 2017</study_first_posted>
  <last_update_submitted>September 1, 2020</last_update_submitted>
  <last_update_submitted_qc>September 1, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 2, 2020</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>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/NCT03261271
org study id: STUDY00141060
secondary id: RSG-17-050-01-NEC
nct id: NCT03261271
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to test how a weight management program affects substances in
      the blood called biomarkers that can show the presence or severity of cancer, compared to a
      standardized diet and exercise educational flyer.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Impact of weight loss before and weight maintenance after Prostate Cancer (PCa) surgery on immunosuppressive factors
time frame: Change from Baseline to Month 6
description: Impact will be measured by changes in specific blood immune biomarker biomarkers.
measure: Impact of weight loss before and weight maintenance after PCa surgery on inflammation factors
time frame: Change from Baseline to Month 6
description: Impact will be measured by changes in specific blood inflammation biomarkers.
measure: Change in weight
time frame: Change from Baseline to Month 6
measure: Change in body composition
time frame: Change from Baseline to Prior to Surgery, from 4 to 16 weeks
description: Body composition will be measured using a Dual Energy X-Ray Absorptiometry (iDXA).
measure: Change in Quality of Life
time frame: Change from Baseline to Month 6
description: Quality of Life will be measured using the Expanded PCa Index Composite (EPIC) Instrument-26. There are a total of 26 items on the survey. Scores range from 0 to 100. The higher the score, the higher the quality of life.
arm group label: Weight Loss and Weight Maintenance
arm group type: Experimental
description: Participants will take part in a weight loss program for at least 4 weeks (and up to 16 weeks) before their prostatectomy, and a weight maintenance program for 6 months after their surgery.
arm group label: Control
arm group type: Active Comparator
description: Participants will receive a standardized educational flyer about a healthy diet and exercise.
intervention type: Behavioral
intervention name: Weight Loss Program
description: Program involves one-on-one coaching, diet meal plan, and physical activity plan.
arm group label: Weight Loss and Weight Maintenance
intervention type: Behavioral
intervention name: Standardized educational flyer
description: The American Institute for Cancer Research handout "Nutrition and the Cancer Survivor" will be provided to participants.
arm group label: Control
intervention type: Behavioral
intervention name: Weight Maintenance Program
description: Post-surgery program involves group support sessions, phone check-ins, and diet and exercise monitoring.
arm group label: Weight Loss and Weight Maintenance
criteria: 
gender: Male
gender based: Yes
minimum age: 50 Years
maximum age: N/A
healthy volunteers: No
last name: Jill Hamilton-Reeves, PhD
role: Principal Investigator
affiliation: University of Kansas Medical Center
facility: 
country: United States
responsible party type: Sponsor
mesh term: Prostatic Neoplasms