<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/NCT03824652</url>
  </required_header>
  <id_info>
    <org_study_id>IIT2018-23-Freedland-POWR</org_study_id>
    <nct_id>NCT03824652</nct_id>
  </id_info>
  <brief_title>WALNUTS for POWER: Polyphenols, Omega-3 Fatty Acids, Weight Loss, and EneRgy</brief_title>
  <official_title>WALNUTS for POWER: Polyphenols, Omega-3 Fatty Acids, Weight Loss, and EneRgy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Stephen Freedland</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>California Walnut Commission</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Cedars-Sinai Medical Center</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>
      This is a randomized control trial testing the effect of walnut supplementation on prostate&#xD;
      cancer progression in 50 men with biopsy confirmed prostate cancer and planning to undergo&#xD;
      RP. Patients consented to the study will be randomly assigned to either continue their usual&#xD;
      diets (control arm) or to the walnut arm for 4-10 weeks depending on the window between their&#xD;
      consent date and the date for RP.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The overall objective of this study is to test the effect of walnuts added to a usual diet on&#xD;
      prostate cancer progression as measured by Ki67 expression in the prostate tissues. Subjects&#xD;
      will be randomized 1:1 to usual diet or usual diet with the addition of 2 ounces of walnuts&#xD;
      daily. The baseline visit will occur in conjunction with a standard of care visit&#xD;
      post-biopsy, the intervention period will range from 4-10 weeks dependent upon the scheduled&#xD;
      date of the standard of care radical prostatectomy (RP), and the final visit will occur in&#xD;
      conjunction with a standard of care visit prior to RP.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">April 22, 2019</start_date>
  <completion_date type="Anticipated">January 2026</completion_date>
  <primary_completion_date type="Anticipated">January 2025</primary_completion_date>
  <phase>Phase 2</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Mean difference in prostatic tissue Ki67 expression from baseline biopsy to RP</measure>
    <time_frame>10 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mean difference in prostatic tissue oxidative stress from baseline biopsy to RP</measure>
    <time_frame>10 weeks</time_frame>
    <description>Measured by prostate tissue 8-hydroxy-2-deoxyguanosine</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean difference in prostatic tissue inflammation from baseline biopsy to RP</measure>
    <time_frame>10 weeks</time_frame>
    <description>Measured by 8-hydroxy-2-deoxyguanosine and immune cell infiltration</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Prostate Cancer</condition>
  <arm_group>
    <arm_group_label>Usual Diet + Walnuts</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Usual diet with the addition of two ounces of walnuts daily, phone counseling with dietitian, for 4-10 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual Diet</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Usual diet for 4-10 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>walnuts</intervention_name>
    <description>2 ounces of walnuts daily for 4-10 weeks</description>
    <arm_group_label>Usual Diet + Walnuts</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>usual diet</intervention_name>
    <description>Subject continues usual diet</description>
    <arm_group_label>Usual Diet</arm_group_label>
    <arm_group_label>Usual Diet + Walnuts</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>phone counseling with dietitian</intervention_name>
    <description>Weekly calls with dietitian</description>
    <arm_group_label>Usual Diet + Walnuts</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Pathologically confirmed prostate adenocarcinoma.&#xD;
&#xD;
          -  Diagnostic biopsy cores with ≥10 cores with each core examined separately to determine&#xD;
             exact tumor location.&#xD;
&#xD;
          -  Biopsy grade group 2 or higher (Gleason ≥7).&#xD;
&#xD;
          -  Planning to undergo RP.&#xD;
&#xD;
          -  Willing to adhere to a usual diet with the possible addition of 2 oz of walnuts per&#xD;
             day.&#xD;
&#xD;
          -  Reads, writes, and understands English.&#xD;
&#xD;
          -  Age 18 or older&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Allergy to nuts.&#xD;
&#xD;
          -  History of receiving hormone therapy or antiandrogen therapy.&#xD;
&#xD;
          -  Use of 5-alpha reductase inhibitors in the past 6 months.&#xD;
&#xD;
          -  Prior prostate radiotherapy (external beam or brachytherapy) or prior prostate&#xD;
             cryotherapy.&#xD;
&#xD;
          -  Currently enrolled in a modified diet/weight loss program and/or taking dietary&#xD;
             supplements that contain omega-3s (e.g., fish oil).&#xD;
&#xD;
          -  Other active malignancy, excluding basal cell carcinoma or squamous cell carcinoma&#xD;
&#xD;
          -  Significant co-morbidities (e.g., cardiac, pulmonary, liver disease, alcohol/drug&#xD;
             addiction, malabsorption syndromes), that in the opinion of the study physician make&#xD;
             the patient ineligible.&#xD;
&#xD;
          -  Individuals with psychological/mental conditions which can affect the consent process&#xD;
             and/or their adherence to the protocol.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Stephen Freedland, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cedars-Sinai Medical Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Yunhee Choi-Kuaea, MSW</last_name>
    <phone>310-423-0333</phone>
    <email>Yunhee.Choi-Kuaea@cshs.org</email>
  </overall_contact>
  <location>
    <facility>
      <name>Cedars-Sinai Medical Center</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90048</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yunhee Choi-Kuaea, MSW</last_name>
      <phone>310-423-0333</phone>
      <email>Yunhee.Choi-Kuaea@cshs.org</email>
    </contact>
    <investigator>
      <last_name>Stephen Freedland, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Durham VA Medical Center</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27705</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Aubrey Jarman, RD</last_name>
      <phone>919-286-0411</phone>
      <email>Aubrey.Jarman@va.gov</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>January 29, 2019</study_first_submitted>
  <study_first_submitted_qc>January 29, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 31, 2019</study_first_posted>
  <last_update_submitted>April 25, 2023</last_update_submitted>
  <last_update_submitted_qc>April 25, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 27, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Cedars-Sinai Medical Center</investigator_affiliation>
    <investigator_full_name>Stephen Freedland</investigator_full_name>
    <investigator_title>Professor, Surgery</investigator_title>
  </responsible_party>
  <keyword>prostate cancer</keyword>
  <keyword>prostate adenocarcinoma</keyword>
  <keyword>diet</keyword>
  <keyword>walnuts</keyword>
  <keyword>radical prostatectomy</keyword>
  <keyword>omega-3 fatty acids</keyword>
  <keyword>polyphenols</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prostatic Neoplasms</mesh_term>
    <mesh_term>Weight Loss</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/NCT03824652
org study id: IIT2018-23-Freedland-POWR
nct id: NCT03824652
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This is a randomized control trial testing the effect of walnut supplementation on prostate
      cancer progression in 50 men with biopsy confirmed prostate cancer and planning to undergo
      RP. Patients consented to the study will be randomly assigned to either continue their usual
      diets (control arm) or to the walnut arm for 4-10 weeks depending on the window between their
      consent date and the date for RP.
The overall objective of this study is to test the effect of walnuts added to a usual diet on
      prostate cancer progression as measured by Ki67 expression in the prostate tissues. Subjects
      will be randomized 1:1 to usual diet or usual diet with the addition of 2 ounces of walnuts
      daily. The baseline visit will occur in conjunction with a standard of care visit
      post-biopsy, the intervention period will range from 4-10 weeks dependent upon the scheduled
      date of the standard of care radical prostatectomy (RP), and the final visit will occur in
      conjunction with a standard of care visit prior to RP.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Mean difference in prostatic tissue Ki67 expression from baseline biopsy to RP
time frame: 10 weeks
measure: Mean difference in prostatic tissue oxidative stress from baseline biopsy to RP
time frame: 10 weeks
description: Measured by prostate tissue 8-hydroxy-2-deoxyguanosine
measure: Mean difference in prostatic tissue inflammation from baseline biopsy to RP
time frame: 10 weeks
description: Measured by 8-hydroxy-2-deoxyguanosine and immune cell infiltration
arm group label: Usual Diet + Walnuts
arm group type: Experimental
description: Usual diet with the addition of two ounces of walnuts daily, phone counseling with dietitian, for 4-10 weeks
arm group label: Usual Diet
arm group type: Active Comparator
description: Usual diet for 4-10 weeks
intervention type: Other
intervention name: walnuts
description: 2 ounces of walnuts daily for 4-10 weeks
arm group label: Usual Diet + Walnuts
intervention type: Other
intervention name: usual diet
description: Subject continues usual diet
arm group label: Usual Diet
arm group label: Usual Diet + Walnuts
intervention type: Other
intervention name: phone counseling with dietitian
description: Weekly calls with dietitian
arm group label: Usual Diet + Walnuts
criteria: 
gender: Male
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Stephen Freedland, MD
role: Principal Investigator
affiliation: Cedars-Sinai Medical Center
last name: Yunhee Choi-Kuaea, MSW
phone: 310-423-0333
email: Yunhee.Choi-Kuaea@cshs.org
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Sponsor-Investigator
investigator affiliation: Cedars-Sinai Medical Center
investigator full name: Stephen Freedland
investigator title: Professor, Surgery
mesh term: Prostatic Neoplasms
mesh term: Weight Loss