<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/NCT02983279</url>
  </required_header>
  <id_info>
    <org_study_id>16D.501</org_study_id>
    <nct_id>NCT02983279</nct_id>
  </id_info>
  <brief_title>Caloric Restriction Before Surgery in Treating Patients With Endometrial, Prostate, or Breast Cancer</brief_title>
  <official_title>Caloric Restriction for Oncology Research: Pre-operative Caloric Restriction Prior to Definitive Oncologic Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sidney Kimmel Cancer Center at Thomas Jefferson University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Thomas Jefferson University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this trial is to determine that sort term calorie restriction will affect&#xD;
      tumor biology in biopsy proven breast, endometrial or prostate cancers, which will positively&#xD;
      impact biomarkers including miR-21, an onco-miR known to impact cancer outcomes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PRIMARY OBJECTIVES:&#xD;
&#xD;
      1) Investigate if caloric restriction will change serum micro ribonucleic acid (RNA) 21&#xD;
      (miR-21) expression in patients with prostate, endometrial or breast cancer.&#xD;
&#xD;
      SECONDARY OBJECTIVES:&#xD;
&#xD;
        1. Investigate measurable changes induced by caloric restriction on both patient (host) and&#xD;
           tumor characteristics from caloric restriction.&#xD;
&#xD;
        2. Investigate the adherence of the patient to the diet.&#xD;
&#xD;
      4) Weight, height, and body composition will be assessed via BodyMetrix. BodyMetrix uses&#xD;
      ultrasound technology to measure subcutaneous fat.&#xD;
&#xD;
      5) Patients will have psycho-social evaluation using the Functional Assessment of Cancer&#xD;
      Therapy-Prostate (FACT-P) test (prostate cancer), FACT-Breast (B) test (breast cancer), or&#xD;
      the FACT-Endometrial Cancer (En) test (endometrial cancer) and the Patient Reported Outcomes&#xD;
      Measurement Information System (PROMIS) cancer fatigue short form at baseline, midway through&#xD;
      diet, and at the conclusion of the diet.&#xD;
&#xD;
      6) Patient's nutritional status (Mini Nutritional Assessment [MNA] form) will be assessed,&#xD;
      and their caloric needs will be calculated.&#xD;
&#xD;
      7) Local recurrence, progression free survival, distant metastases and overall survival will&#xD;
      be assessed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 20, 2016</start_date>
  <completion_date type="Actual">December 29, 2022</completion_date>
  <primary_completion_date type="Actual">October 27, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in miR-21 expression assessed in serum</measure>
    <time_frame>Baseline up to 12 weeks</time_frame>
    <description>Will be evaluated by a two-sided paired t-test at significance level 0.05.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall adherence with diet intervention defined as 90% of all logged events meeting the diet restriction target</measure>
    <time_frame>Up to 12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in body composition, assessed via BodyMetrix</measure>
    <time_frame>Baseline up to 12 weeks</time_frame>
    <description>Will be analyzed via a paired t-test.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in prostate tumor gene expression</measure>
    <time_frame>Baseline up to 12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in weight, defined as a percent change</measure>
    <time_frame>Baseline up to 12 weeks</time_frame>
    <description>Will be assessed by modeling BMI as a function of time via mixed-effects regression.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in temperature</measure>
    <time_frame>Baseline up to 12 weeks</time_frame>
    <description>Will be assessed as a function of time via mixed-effects regression.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in genomic expression of microRNA 21 (miR-21)</measure>
    <time_frame>Baseline to after definitive surgery</time_frame>
    <description>Initial cancer biopsy specimen for genomic analysis will be comped to definitive surgical specimens.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in insulin</measure>
    <time_frame>Baseline up to 12 weeks</time_frame>
    <description>Will be assessed as a function of time via mixed-effects regression.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in biome analysis assessed by rectal swab</measure>
    <time_frame>Baseline to 12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in psycho-social outcomes, assessed by the FACT-B</measure>
    <time_frame>Baseline up to 12 weeks</time_frame>
    <description>Will be assessed as a function of time via mixed-effects regression.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in nutritional status assessed by a Mini Nutritional Assessment (MNA)</measure>
    <time_frame>Baseline up to 12 weeks</time_frame>
    <description>Will be assessed as a function of time via mixed-effects regression.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Local recurrence, assessed through patient records</measure>
    <time_frame>From the date of study enrollment to time of event, assessed up to 12 weeks</time_frame>
    <description>Will be analyzed via survival methods, specifically the Kaplan-Meier method and the log-rank test. If sufficient events occur, may assess the impact of various patient and clinical/treatment variables on these outcomes via Cox proportional hazards regression. Will be assessed and compared with historic controls using the Kaplan Meier method.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Distant metastases, assessed through patient records</measure>
    <time_frame>From the date of study enrollment to time of event, assessed up to 12 weeks</time_frame>
    <description>Will be analyzed via survival methods, specifically the Kaplan-Meier method and the log-rank test. If sufficient events occur, may assess the impact of various patient and clinical/treatment variables on these outcomes via Cox proportional hazards regression. Will be assessed and compared with historic controls using the Kaplan Meier method.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression free survival, assessed through patient records</measure>
    <time_frame>From the date of study enrollment to time of event, assessed up to 12 weeks</time_frame>
    <description>Will be analyzed via survival methods, specifically the Kaplan-Meier method and the log-rank test. If sufficient events occur, may assess the impact of various patient and clinical/treatment variables on these outcomes via Cox proportional hazards regression. Will be assessed and compared with historic controls using the Kaplan Meier method.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall survival, assessed through patient records</measure>
    <time_frame>From the date of study enrollment to time of event, assessed up to 12 weeks</time_frame>
    <description>Will be analyzed via survival methods, specifically the Kaplan-Meier method and the log-rank test. If sufficient events occur, may assess the impact of various patient and clinical/treatment variables on these outcomes via Cox proportional hazards regression. Will be assessed and compared with historic controls using the Kaplan Meier method.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in weight, defined by body mass index as weight in kg divided by height in meters squared</measure>
    <time_frame>Baseline up to 12 weeks</time_frame>
    <description>Will be assessed by modeling BMI as a function of time via mixed-effects regression.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in blood pressure</measure>
    <time_frame>Baseline up to 12 weeks</time_frame>
    <description>Will be assessed as a function of time via mixed-effects regression.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in heart rate</measure>
    <time_frame>Baseline up to 12 weeks</time_frame>
    <description>Will be assessed as a function of time via mixed-effects regression.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in respiratory rate</measure>
    <time_frame>Baseline up to 12 weeks</time_frame>
    <description>Will be assessed as a function of time via mixed-effects regression.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in psycho-social outcomes, assessed by the FACT-P</measure>
    <time_frame>Baseline up to 12 weeks</time_frame>
    <description>Will be assessed as a function of time via mixed-effects regression.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in psycho-social outcomes, assessed by the FACT-En</measure>
    <time_frame>Baseline up to 12 weeks</time_frame>
    <description>Will be assessed as a function of time via mixed-effects regression.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in psycho-social outcomes, assessed by the POMIS cancer fatigue short form</measure>
    <time_frame>Baseline up to 12 weeks</time_frame>
    <description>Will be assessed as a function of time via mixed-effects regression.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">49</enrollment>
  <condition>Breast Carcinoma</condition>
  <condition>Endometrial Carcinoma</condition>
  <condition>Prostate Carcinosarcoma</condition>
  <arm_group>
    <arm_group_label>Dietary counseling, caloric restriction diet</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients then undergo 25% caloric intake for 3-12 weeks prior to definitive cancer surgery.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Dietary Intervention</intervention_name>
    <description>Undergo caloric restriction diet</description>
    <arm_group_label>Dietary counseling, caloric restriction diet</arm_group_label>
    <other_name>Dietary Modification</other_name>
    <other_name>Nutrition Intervention</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Counseling</intervention_name>
    <description>Undergo counselor-led dietary counseling</description>
    <arm_group_label>Dietary counseling, caloric restriction diet</arm_group_label>
    <other_name>Counseling Intervention</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Therapeutic</intervention_name>
    <description>Undergo standard of care surgery</description>
    <arm_group_label>Dietary counseling, caloric restriction diet</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Histological documentation of cancer of the endometrium, prostate or breast.&#xD;
&#xD;
          2. Candidate for definitive cancer surgery as determined by treating physician&#xD;
&#xD;
          3. The ability for the definitive cancer surgery to be scheduled within 4-12 weeks post&#xD;
             initiation of dietary intervention as determined by the enrolling physician (not from&#xD;
             diagnosis - but from start of diet).&#xD;
&#xD;
          4. No other malignancy within the past 6 months unless it was a non-melanomatous skin&#xD;
             lesion&#xD;
&#xD;
          5. BMI ≥21&#xD;
&#xD;
          6. ECOG Performance Status of 2 or less&#xD;
&#xD;
          7. Patient must not be on anti-retrovirals since they may alter patient metabolism&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patient is not a candidate for definitive cancer surgery&#xD;
&#xD;
          2. Definitive cancer surgery can not be performed within 4-12 weeks post study enrollment&#xD;
             as determined by the enrolling physician.&#xD;
&#xD;
          3. Body Mass Index &lt; 21&#xD;
&#xD;
          4. Another malignancy within the past 6 months that was not a non-melanomatous skin&#xD;
             lesion&#xD;
&#xD;
          5. ECOG Performance Status &gt;2&#xD;
&#xD;
          6. Patient on anti-retrovirals since they may alter patient metabolism&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nicole Simone, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Sidney Kimmel Cancer Center at Thomas Jefferson University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Thomas Jefferson University</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19107</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://hospitals.jefferson.edu/</url>
    <description>Thomas Jefferson University Hospital</description>
  </link>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>November 14, 2016</study_first_submitted>
  <study_first_submitted_qc>December 1, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 6, 2016</study_first_posted>
  <last_update_submitted>January 4, 2023</last_update_submitted>
  <last_update_submitted_qc>January 4, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 6, 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>Carcinoma</mesh_term>
    <mesh_term>Breast Neoplasms</mesh_term>
    <mesh_term>Endometrial Neoplasms</mesh_term>
    <mesh_term>Carcinosarcoma</mesh_term>
    <mesh_term>Mixed Tumor, Mullerian</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/NCT02983279
org study id: 16D.501
nct id: NCT02983279
lead sponsor: 
has dmc: Yes
The purpose of this trial is to determine that sort term calorie restriction will affect
      tumor biology in biopsy proven breast, endometrial or prostate cancers, which will positively
      impact biomarkers including miR-21, an onco-miR known to impact cancer outcomes.
PRIMARY OBJECTIVES:

      1) Investigate if caloric restriction will change serum micro ribonucleic acid (RNA) 21
      (miR-21) expression in patients with prostate, endometrial or breast cancer.

      SECONDARY OBJECTIVES:

        1. Investigate measurable changes induced by caloric restriction on both patient (host) and
           tumor characteristics from caloric restriction.

        2. Investigate the adherence of the patient to the diet.

      4) Weight, height, and body composition will be assessed via BodyMetrix. BodyMetrix uses
      ultrasound technology to measure subcutaneous fat.

      5) Patients will have psycho-social evaluation using the Functional Assessment of Cancer
      Therapy-Prostate (FACT-P) test (prostate cancer), FACT-Breast (B) test (breast cancer), or
      the FACT-Endometrial Cancer (En) test (endometrial cancer) and the Patient Reported Outcomes
      Measurement Information System (PROMIS) cancer fatigue short form at baseline, midway through
      diet, and at the conclusion of the diet.

      6) Patient's nutritional status (Mini Nutritional Assessment [MNA] form) will be assessed,
      and their caloric needs will be calculated.

      7) Local recurrence, progression free survival, distant metastases and overall survival will
      be assessed.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in miR-21 expression assessed in serum
time frame: Baseline up to 12 weeks
description: Will be evaluated by a two-sided paired t-test at significance level 0.05.
measure: Overall adherence with diet intervention defined as 90% of all logged events meeting the diet restriction target
time frame: Up to 12 weeks
measure: Change in body composition, assessed via BodyMetrix
time frame: Baseline up to 12 weeks
description: Will be analyzed via a paired t-test.
measure: Change in prostate tumor gene expression
time frame: Baseline up to 12 weeks
measure: Change in weight, defined as a percent change
time frame: Baseline up to 12 weeks
description: Will be assessed by modeling BMI as a function of time via mixed-effects regression.
measure: Change in temperature
time frame: Baseline up to 12 weeks
description: Will be assessed as a function of time via mixed-effects regression.
measure: Change in genomic expression of microRNA 21 (miR-21)
time frame: Baseline to after definitive surgery
description: Initial cancer biopsy specimen for genomic analysis will be comped to definitive surgical specimens.
measure: Change in insulin
time frame: Baseline up to 12 weeks
description: Will be assessed as a function of time via mixed-effects regression.
measure: Change in biome analysis assessed by rectal swab
time frame: Baseline to 12 weeks
measure: Change in psycho-social outcomes, assessed by the FACT-B
time frame: Baseline up to 12 weeks
description: Will be assessed as a function of time via mixed-effects regression.
measure: Changes in nutritional status assessed by a Mini Nutritional Assessment (MNA)
time frame: Baseline up to 12 weeks
description: Will be assessed as a function of time via mixed-effects regression.
measure: Local recurrence, assessed through patient records
time frame: From the date of study enrollment to time of event, assessed up to 12 weeks
description: Will be analyzed via survival methods, specifically the Kaplan-Meier method and the log-rank test. If sufficient events occur, may assess the impact of various patient and clinical/treatment variables on these outcomes via Cox proportional hazards regression. Will be assessed and compared with historic controls using the Kaplan Meier method.
measure: Distant metastases, assessed through patient records
time frame: From the date of study enrollment to time of event, assessed up to 12 weeks
description: Will be analyzed via survival methods, specifically the Kaplan-Meier method and the log-rank test. If sufficient events occur, may assess the impact of various patient and clinical/treatment variables on these outcomes via Cox proportional hazards regression. Will be assessed and compared with historic controls using the Kaplan Meier method.
measure: Progression free survival, assessed through patient records
time frame: From the date of study enrollment to time of event, assessed up to 12 weeks
description: Will be analyzed via survival methods, specifically the Kaplan-Meier method and the log-rank test. If sufficient events occur, may assess the impact of various patient and clinical/treatment variables on these outcomes via Cox proportional hazards regression. Will be assessed and compared with historic controls using the Kaplan Meier method.
measure: Overall survival, assessed through patient records
time frame: From the date of study enrollment to time of event, assessed up to 12 weeks
description: Will be analyzed via survival methods, specifically the Kaplan-Meier method and the log-rank test. If sufficient events occur, may assess the impact of various patient and clinical/treatment variables on these outcomes via Cox proportional hazards regression. Will be assessed and compared with historic controls using the Kaplan Meier method.
measure: Change in weight, defined by body mass index as weight in kg divided by height in meters squared
time frame: Baseline up to 12 weeks
description: Will be assessed by modeling BMI as a function of time via mixed-effects regression.
measure: Change in blood pressure
time frame: Baseline up to 12 weeks
description: Will be assessed as a function of time via mixed-effects regression.
measure: Change in heart rate
time frame: Baseline up to 12 weeks
description: Will be assessed as a function of time via mixed-effects regression.
measure: Change in respiratory rate
time frame: Baseline up to 12 weeks
description: Will be assessed as a function of time via mixed-effects regression.
measure: Change in psycho-social outcomes, assessed by the FACT-P
time frame: Baseline up to 12 weeks
description: Will be assessed as a function of time via mixed-effects regression.
measure: Change in psycho-social outcomes, assessed by the FACT-En
time frame: Baseline up to 12 weeks
description: Will be assessed as a function of time via mixed-effects regression.
measure: Change in psycho-social outcomes, assessed by the POMIS cancer fatigue short form
time frame: Baseline up to 12 weeks
description: Will be assessed as a function of time via mixed-effects regression.
arm group label: Dietary counseling, caloric restriction diet
arm group type: Experimental
description: Patients then undergo 25% caloric intake for 3-12 weeks prior to definitive cancer surgery.
intervention type: Dietary Supplement
intervention name: Dietary Intervention
description: Undergo caloric restriction diet
arm group label: Dietary counseling, caloric restriction diet
other name: Dietary Modification
other name: Nutrition Intervention
intervention type: Other
intervention name: Counseling
description: Undergo counselor-led dietary counseling
arm group label: Dietary counseling, caloric restriction diet
other name: Counseling Intervention
intervention type: Procedure
intervention name: Therapeutic
description: Undergo standard of care surgery
arm group label: Dietary counseling, caloric restriction diet
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Nicole Simone, MD
role: Principal Investigator
affiliation: Sidney Kimmel Cancer Center at Thomas Jefferson University
facility: 
country: United States
url: http://hospitals.jefferson.edu/
description: Thomas Jefferson University Hospital
responsible party type: Sponsor
mesh term: Carcinoma
mesh term: Breast Neoplasms
mesh term: Endometrial Neoplasms
mesh term: Carcinosarcoma
mesh term: Mixed Tumor, Mullerian