<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/NCT03042897</url>
  </required_header>
  <id_info>
    <org_study_id>5U-16-1</org_study_id>
    <secondary_id>NCI-2016-01684</secondary_id>
    <secondary_id>5U-16-1</secondary_id>
    <secondary_id>P30CA014089</secondary_id>
    <nct_id>NCT03042897</nct_id>
  </id_info>
  <brief_title>Exercise and Diet Intervention in Promoting Weight Loss in Obese Patients With Stage I Endometrial Cancer</brief_title>
  <official_title>Endometrial Cancer and Obesity: An Exercise and Diet Intervention for Weight Loss</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Southern California</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Southern California</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 pilot clinical trial studies exercise and diet intervention in promoting weight loss in&#xD;
      obese patients with stage I endometrial cancer. Exercise and diet may cause weight loss and&#xD;
      minimize the risk of gynecologic surgery related to being overweight in patients with&#xD;
      endometrial cancer.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PRIMARY OBJECTIVES:&#xD;
&#xD;
      I. To determine if participation in a 16-week exercise and diet intervention would elicit&#xD;
      weight loss, assessed by a 10% decrease in fat mass, in endometrial cancer (EC) patients.&#xD;
&#xD;
      SECONDARY OBJECTIVES:&#xD;
&#xD;
      I. To determine if participation in a 16-week exercise and diet intervention would improve&#xD;
      cardiorespiratory fitness (CRF) and muscular strength.&#xD;
&#xD;
      TERTIARY OBJECTIVES:&#xD;
&#xD;
      I. To determine if participation in a 16-week exercise and diet intervention could improve&#xD;
      quality of life (QOL), fatigue, and depression.&#xD;
&#xD;
      II. To determine the effects of a 16-week exercise and diet intervention on cardiovascular&#xD;
      (CV) health.&#xD;
&#xD;
      OUTLINE:&#xD;
&#xD;
      Patients undergo aerobic exercise thrice weekly over 95 minutes for up to 16 weeks. Patients&#xD;
      also undergo multi-lifestyle interventions based on the dietary approaches to stop&#xD;
      hypertension (DASH) diet once weekly over 1 hour for up to 16 weeks.&#xD;
&#xD;
      After completion of study, patients are followed up for 16 weeks.&#xD;
&#xD;
      After completion of study, patients are followed up for 16 weeks.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    PI left institution&#xD;
  </why_stopped>
  <start_date type="Actual">September 8, 2017</start_date>
  <completion_date type="Actual">July 31, 2019</completion_date>
  <primary_completion_date type="Actual">July 31, 2019</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>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Cardiorespiratory Fitness (CRF)</measure>
    <time_frame>Up to 34 weeks</time_frame>
    <description>Subjects will be instructed to walk comfortably (so they are able to talk while walking) on a treadmill for 4 minutes and heart rate will be measured at the end of the test to estimate maximal oxygen uptake.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cardiovascular (CV) health outcomes</measure>
    <time_frame>Up to 34 weeks</time_frame>
    <description>Carotid Intima Media Thickness (cIMT) of the right common carotid artery will be measured using B-mode ultrasound. The ultrasound scan of cIMT provides lumen diameter, intima-media thickness, and presence and extent of plaques.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Depression measured by Center for Epidemiologic Studies Depression scale</measure>
    <time_frame>Up to 34 weeks</time_frame>
    <description>Will be assessed on a continuum scale and thus our current plan is to use paired t tests. All analysis will be performed using SPSS (v.21).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Fatigue measured by the Brief Fatigue Inventory</measure>
    <time_frame>Up to 34 weeks</time_frame>
    <description>Will be assessed on a continuum scale and thus our current plan is to use paired t tests. All analysis will be performed using SPSS (v.21).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Muscle strength</measure>
    <time_frame>Up to 34 weeks</time_frame>
    <description>The 10-repetition maximum (10-RM) method will test maximal voluntary strength for the following exercises: chest press, seated row, knee extension, knee flexion will be used to calculate maximum strength values for the resistance exercise intervention.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percent weight loss at the completion of the intervention</measure>
    <time_frame>At 16 weeks</time_frame>
    <description>Each of the 25 women will be classified as having achieve the 10% weight-loss or not. Of those subjects who achieve a weight-loss of 10% or more, the proportion of patients who maintain this weight-loss will also be calculated. The mean percent weight loss, as well as the range and quartiles will be calculated. In addition, for those subjects who fail to achieve a 10% weight-loss, the reasons for failure will be examined (e.g. inability to complete 16 weeks, inability to adhere to the diet, inability to adhere to the exercise schedule, etc.). This information will guide the design (or redesign of the weight loss program as well as the follow-up studies.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Quality of Life (QOL)</measure>
    <time_frame>Up to 34 weeks</time_frame>
    <description>The SF-36 short-form health survey with 36 items will be used to assess physical and mental health. The FACT-En questionnaire will also be used. This is a 43-item questionnaire including questions regarding the physical well-being, social/family well-being, and additional concerns on the effect of endometrial cancer on the participants.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Estrogen Receptor Positive</condition>
  <condition>Obesity</condition>
  <condition>Progesterone Receptor Positive</condition>
  <condition>Stage I Uterine Corpus Cancer</condition>
  <condition>Stage IA Uterine Corpus Cancer</condition>
  <condition>Stage IB Uterine Corpus Cancer</condition>
  <arm_group>
    <arm_group_label>Supportive Care (exercise and diet)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients undergo aerobic exercise thrice weekly over 95 minutes for up to 16 weeks. Patients also undergo multi-lifestyle interventions based on the DASH diet once weekly over 1 hour for up to 16 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Dietary Intervention</intervention_name>
    <description>Undergo DASH diet</description>
    <arm_group_label>Supportive Care (exercise and diet)</arm_group_label>
    <other_name>Dietary Modification</other_name>
    <other_name>intervention, dietary</other_name>
    <other_name>Nutrition Intervention</other_name>
    <other_name>Nutrition Interventions</other_name>
    <other_name>Nutritional Interventions</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Exercise Intervention</intervention_name>
    <description>Undergo in aerobic exercise</description>
    <arm_group_label>Supportive Care (exercise and diet)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Laboratory Biomarker Analysis</intervention_name>
    <description>Correlative studies</description>
    <arm_group_label>Supportive Care (exercise and diet)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Quality-of-Life Assessment</intervention_name>
    <description>Ancillary studies</description>
    <arm_group_label>Supportive Care (exercise and diet)</arm_group_label>
    <other_name>Quality of Life Assessment</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Clinical stage I EC&#xD;
&#xD;
          -  Low grade disease positive for estrogen and progesterone receptors&#xD;
&#xD;
          -  Body mass index (BMI) &gt;= 30 kg/m^2&#xD;
&#xD;
          -  No history of any musculoskeletal, cardiorespiratory or neurological diseases that&#xD;
             preclude the participation in exercise&#xD;
&#xD;
          -  Self ambulatory and without use of assistive walking devices&#xD;
&#xD;
          -  Is not a candidate for immediate hysterectomy, following evaluation by a physician,&#xD;
             due to desire to preserve fertility, due to degree of obesity, due to comorbidities,&#xD;
             or due to patient refusal of hysterectomy&#xD;
&#xD;
          -  Must agree to take progestin agents (i.e., oral agents or MIRENA intrauterine device&#xD;
             [IUD] which are accepted treatments for low grade uterine malignancies to control&#xD;
             their disease while the intervention is ongoing)&#xD;
&#xD;
               -  Note: potential participants WILL NOT be asked to delay surgery to participate in&#xD;
                  this pilot study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with metastatic disease&#xD;
&#xD;
          -  BMI =&lt; 29.9 kg/m^2&#xD;
&#xD;
          -  History of any musculoskeletal, cardiorespiratory or neurological diseases that&#xD;
             preclude the participation in exercise&#xD;
&#xD;
          -  Is not self ambulatory and relies on the use of assistive walking devices&#xD;
&#xD;
          -  Is a candidate for immediate hysterectomy, following evaluation by a physician&#xD;
&#xD;
          -  In judgement of a physician, is not a candidate for progestin agents&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Christina Dieli-Conwright, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Southern California</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>USC / Norris Comprehensive Cancer Center</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90033</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2020</verification_date>
  <study_first_submitted>February 1, 2017</study_first_submitted>
  <study_first_submitted_qc>February 1, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 3, 2017</study_first_posted>
  <last_update_submitted>December 15, 2020</last_update_submitted>
  <last_update_submitted_qc>December 15, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">December 17, 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>Endometrial Neoplasms</mesh_term>
    <mesh_term>Obesity</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/NCT03042897
org study id: 5U-16-1
secondary id: NCI-2016-01684
secondary id: 5U-16-1
secondary id: P30CA014089
nct id: NCT03042897
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This pilot clinical trial studies exercise and diet intervention in promoting weight loss in
      obese patients with stage I endometrial cancer. Exercise and diet may cause weight loss and
      minimize the risk of gynecologic surgery related to being overweight in patients with
      endometrial cancer.
PRIMARY OBJECTIVES:

      I. To determine if participation in a 16-week exercise and diet intervention would elicit
      weight loss, assessed by a 10% decrease in fat mass, in endometrial cancer (EC) patients.

      SECONDARY OBJECTIVES:

      I. To determine if participation in a 16-week exercise and diet intervention would improve
      cardiorespiratory fitness (CRF) and muscular strength.

      TERTIARY OBJECTIVES:

      I. To determine if participation in a 16-week exercise and diet intervention could improve
      quality of life (QOL), fatigue, and depression.

      II. To determine the effects of a 16-week exercise and diet intervention on cardiovascular
      (CV) health.

      OUTLINE:

      Patients undergo aerobic exercise thrice weekly over 95 minutes for up to 16 weeks. Patients
      also undergo multi-lifestyle interventions based on the dietary approaches to stop
      hypertension (DASH) diet once weekly over 1 hour for up to 16 weeks.

      After completion of study, patients are followed up for 16 weeks.

      After completion of study, patients are followed up for 16 weeks.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Cardiorespiratory Fitness (CRF)
time frame: Up to 34 weeks
description: Subjects will be instructed to walk comfortably (so they are able to talk while walking) on a treadmill for 4 minutes and heart rate will be measured at the end of the test to estimate maximal oxygen uptake.
measure: Cardiovascular (CV) health outcomes
time frame: Up to 34 weeks
description: Carotid Intima Media Thickness (cIMT) of the right common carotid artery will be measured using B-mode ultrasound. The ultrasound scan of cIMT provides lumen diameter, intima-media thickness, and presence and extent of plaques.
measure: Depression measured by Center for Epidemiologic Studies Depression scale
time frame: Up to 34 weeks
description: Will be assessed on a continuum scale and thus our current plan is to use paired t tests. All analysis will be performed using SPSS (v.21).
measure: Fatigue measured by the Brief Fatigue Inventory
time frame: Up to 34 weeks
description: Will be assessed on a continuum scale and thus our current plan is to use paired t tests. All analysis will be performed using SPSS (v.21).
measure: Muscle strength
time frame: Up to 34 weeks
description: The 10-repetition maximum (10-RM) method will test maximal voluntary strength for the following exercises: chest press, seated row, knee extension, knee flexion will be used to calculate maximum strength values for the resistance exercise intervention.
measure: Percent weight loss at the completion of the intervention
time frame: At 16 weeks
description: Each of the 25 women will be classified as having achieve the 10% weight-loss or not. Of those subjects who achieve a weight-loss of 10% or more, the proportion of patients who maintain this weight-loss will also be calculated. The mean percent weight loss, as well as the range and quartiles will be calculated. In addition, for those subjects who fail to achieve a 10% weight-loss, the reasons for failure will be examined (e.g. inability to complete 16 weeks, inability to adhere to the diet, inability to adhere to the exercise schedule, etc.). This information will guide the design (or redesign of the weight loss program as well as the follow-up studies.
measure: Quality of Life (QOL)
time frame: Up to 34 weeks
description: The SF-36 short-form health survey with 36 items will be used to assess physical and mental health. The FACT-En questionnaire will also be used. This is a 43-item questionnaire including questions regarding the physical well-being, social/family well-being, and additional concerns on the effect of endometrial cancer on the participants.
arm group label: Supportive Care (exercise and diet)
arm group type: Experimental
description: Patients undergo aerobic exercise thrice weekly over 95 minutes for up to 16 weeks. Patients also undergo multi-lifestyle interventions based on the DASH diet once weekly over 1 hour for up to 16 weeks.
intervention type: Dietary Supplement
intervention name: Dietary Intervention
description: Undergo DASH diet
arm group label: Supportive Care (exercise and diet)
other name: Dietary Modification
other name: intervention, dietary
other name: Nutrition Intervention
other name: Nutrition Interventions
other name: Nutritional Interventions
intervention type: Behavioral
intervention name: Exercise Intervention
description: Undergo in aerobic exercise
arm group label: Supportive Care (exercise and diet)
intervention type: Other
intervention name: Laboratory Biomarker Analysis
description: Correlative studies
arm group label: Supportive Care (exercise and diet)
intervention type: Other
intervention name: Quality-of-Life Assessment
description: Ancillary studies
arm group label: Supportive Care (exercise and diet)
other name: Quality of Life Assessment
criteria: 
gender: Female
minimum age: 19 Years
maximum age: N/A
healthy volunteers: No
last name: Christina Dieli-Conwright, PhD
role: Principal Investigator
affiliation: University of Southern California
facility: 
country: United States
responsible party type: Sponsor
mesh term: Endometrial Neoplasms
mesh term: Obesity
mesh term: Weight Loss