<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/NCT03274349</url>
  </required_header>
  <id_info>
    <org_study_id>EMS Nutr ÖsoBroCA</org_study_id>
    <nct_id>NCT03274349</nct_id>
  </id_info>
  <brief_title>Whole Body Electromyostimulation and Nutritional Therapy for Patients With Esophageal and Bronchial Carcinoma</brief_title>
  <official_title>Influence of Whole Body Electromyostimulation and Nutritional Therapy for Patients With Esophageal and Bronchial Carcinoma in Curative and Palliative Treatment</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Erlangen-Nürnberg Medical School</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Erlangen-Nürnberg Medical School</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 objective or the trial is to study the influence of a combined therapy involving&#xD;
      protein-rich individualized nutritional therapy and highly effective muscle training via&#xD;
      personalized whole-body electromyostimulation exercise on muscle mass, muscle functionality,&#xD;
      physical capability, fatigue and quality of life in patients with esophageal and bronchial&#xD;
      carcinoma in advanced or metastatic stage.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Tumor specific and inflammation promoting mediators lead to a loss of appetite, to systemic&#xD;
      inflammation processes and to metabolic and hormonal changes including anabolic resistance.&#xD;
      Consequences hereof are a decreased food uptake, a deteriorated nutrient utilization and a&#xD;
      loss of muscles and/or fat leading to cancer cachexia. In addition, an accelerated muscle&#xD;
      wasting can be a side effect of the oncologic therapy promoting cancer cachexia even further.&#xD;
      The advancing muscle loss induces diminishing physical capability, a decreased tolerance of&#xD;
      oncological therapy, functional losses even reaching loss of independence and a worsened&#xD;
      prognosis.&#xD;
&#xD;
      The purpose of this study is to establish an innovative combined therapy involving&#xD;
      protein-rich nutritional therapy and highly effective muscle training by personalized&#xD;
      whole-body electromyostimulation (WB-EMS) exercise to improve muscle mass, functionality and&#xD;
      strength of esophageal and bronchial carcinoma patients in advanced stage. An increase in&#xD;
      muscle mass and strength leads to an increase in physical activity, physical capability as&#xD;
      well as tolerance to and applicability of tumor therapy. In the course of a 3-months&#xD;
      intervention study the efficacy of a combined protein-rich nutritional therapy with an&#xD;
      innovative exercise therapy will be documented for patients with esophageal and bronchial&#xD;
      carcinoma in advanced or metastatic stage. An effective stopping of the progress of muscle&#xD;
      wasting or even increase of muscle mass, strength and function in the patients of the trial&#xD;
      would benefit each patient and his family individually, since it could mean a considerable&#xD;
      improvement in his quality of life and tolerability of oncological treatment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">March 17, 2017</start_date>
  <completion_date type="Anticipated">March 2021</completion_date>
  <primary_completion_date type="Anticipated">March 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Prospective, controlled pilot study</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>The patients will be coded by a consecutive numbering. Data will be saved only with this number. Access to the data will only be provided to authorized personnel (study nurses) and will be retained in inaccessable and locked rooms.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Muscle mass maintenance or increase, as assessed by Bioelectrical Impedance Analysis</measure>
    <time_frame>12 weeks per patient</time_frame>
    <description>Maintenance or increase of skeletal muscle mass in patients with esophagus or bronchial carcinoma receiving a combined therapy of protein-rich nutrition and WB-EMS, by assessing Bioelectrical Impedance Analysis values.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Increase in quality of life score by assessing the score points using EORTC-QLQ-C30 questionnaires</measure>
    <time_frame>12 weeks per patient</time_frame>
    <description>Clinical improvement by an increase in quality of life in patients with esophagus or bronchial carcinoma receiving a combined therapy of protein-rich nutrition and WB-EMS.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Increase or maintenance of muscle strength, as assessed by hand grip strength measurements (Jamar dynamometry)</measure>
    <time_frame>12 weeks per patient</time_frame>
    <description>Clinical improvement by an increase in muscle strength in patients with esophagus or bronchial carcinoma receiving a combined therapy of protein-rich nutrition and WB-EMS.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Improvement of pain scores, as assessed by Visual Analog Score</measure>
    <time_frame>12 weeks per patient</time_frame>
    <description>Clinical improvement by an increase of pain scores in patients with esophagus or bronchial carcinoma receiving a combined therapy of protein-rich nutrition and WB-EMS.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Improvement of fatigue scores, as assessed by FACIT-Fatigue Score</measure>
    <time_frame>12 weeks per patient</time_frame>
    <description>Clinical improvement by an increase of fatigue scores in patients with esophagus or bronchial carcinoma receiving a combined therapy of protein-rich nutrition and WB-EMS.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Improvement of oncological therapy tolerance, as assessed by Common Toxicity Criteria regarding gastrointestinal complaints</measure>
    <time_frame>12 weeks per patient</time_frame>
    <description>Clinical improvement oncology therapy tolerance in patients with esophagus or bronchial carcinoma receiving a combined therapy of protein-rich nutrition and WB-EMS.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maintenance or increase in Body Mass Index (BMI) in kg/m^2-analysis (combination of weight in kilograms and height and in meters</measure>
    <time_frame>12 weeks per patient</time_frame>
    <description>Maintenance or increase of skeletal muscle mass in patients with esophagus or bronchial carcinoma receiving a combined therapy of protein-rich nutrition and WB-EMS, by assessing BMI in kg/m^2 (combination of weight in kilograms and height in meters).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">150</enrollment>
  <condition>Cancer of Esophagus</condition>
  <condition>Cancer, Lung</condition>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Group of patients receiving individualized protein-rich nutritional therapy without exercise, 12 weeks intervention per patient</description>
  </arm_group>
  <arm_group>
    <arm_group_label>EMS-group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Group of patients receiving individualized protein-rich nutritional therapy with personalized whole body electromyostimulation exercise, 12 weeks intervention per patient</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>whole body electromyostimulation exercise</intervention_name>
    <description>whole body electromyostimulation exercise training twice a week for 20 min each, bipolar, 85 Hz, intermittent pulse/pause, pulse width 350 µsec</description>
    <arm_group_label>EMS-group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>protein-rich nutrition therapy</intervention_name>
    <description>protein-rich nutrition therapy with an objective of reaching 1,2 to 1,5 g protein/kg body weight and day</description>
    <arm_group_label>Control</arm_group_label>
    <arm_group_label>EMS-group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with esophageal and/or bronchial carcinoma in curative or palliative&#xD;
             treatment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Healthy persons or patients under age&#xD;
&#xD;
          -  Pregnancy, Lactation&#xD;
&#xD;
          -  Psychological disorders, epilepsia, sever neurological disorders&#xD;
&#xD;
          -  Participation in other exercise- or nutrition studies within the last 6 months&#xD;
&#xD;
          -  Acute cardiovascular disease&#xD;
&#xD;
          -  Rheuma&#xD;
&#xD;
          -  Intake of anabolic drugs,&#xD;
&#xD;
          -  Skin injuries in the area of electrode placements&#xD;
&#xD;
          -  Electronic implants (defibrillator, pacemaker)&#xD;
&#xD;
          -  Persons in mental hospitals by order of authorities or jurisdiction&#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>Yurdaguel Zopf, Prof.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Erlangen Nuremberg Medical School</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Yurdaguel Zopf, Prof.</last_name>
    <phone>*49 9131 85-35000</phone>
    <email>yurdaguel.zopf@uk-erlangen.de</email>
  </overall_contact>
  <location>
    <facility>
      <name>University Hospital Erlangen, Department of Medicine 1</name>
      <address>
        <city>Erlangen</city>
        <state>Bavaria</state>
        <zip>91054</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yurdaguel Zopf</last_name>
      <phone>+49 9131 85 35000</phone>
      <email>yurdaguel.zopf@uk-erlangen.de</email>
    </contact>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>October 2018</verification_date>
  <study_first_submitted>May 30, 2017</study_first_submitted>
  <study_first_submitted_qc>September 4, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 6, 2017</study_first_posted>
  <last_update_submitted>October 15, 2018</last_update_submitted>
  <last_update_submitted_qc>October 15, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">October 16, 2018</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>Lung Neoplasms</mesh_term>
    <mesh_term>Esophageal Neoplasms</mesh_term>
    <mesh_term>Carcinoma, Bronchogenic</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT03274349
org study id: EMS Nutr ÖsoBroCA
nct id: NCT03274349
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The objective or the trial is to study the influence of a combined therapy involving
      protein-rich individualized nutritional therapy and highly effective muscle training via
      personalized whole-body electromyostimulation exercise on muscle mass, muscle functionality,
      physical capability, fatigue and quality of life in patients with esophageal and bronchial
      carcinoma in advanced or metastatic stage.
Tumor specific and inflammation promoting mediators lead to a loss of appetite, to systemic
      inflammation processes and to metabolic and hormonal changes including anabolic resistance.
      Consequences hereof are a decreased food uptake, a deteriorated nutrient utilization and a
      loss of muscles and/or fat leading to cancer cachexia. In addition, an accelerated muscle
      wasting can be a side effect of the oncologic therapy promoting cancer cachexia even further.
      The advancing muscle loss induces diminishing physical capability, a decreased tolerance of
      oncological therapy, functional losses even reaching loss of independence and a worsened
      prognosis.

      The purpose of this study is to establish an innovative combined therapy involving
      protein-rich nutritional therapy and highly effective muscle training by personalized
      whole-body electromyostimulation (WB-EMS) exercise to improve muscle mass, functionality and
      strength of esophageal and bronchial carcinoma patients in advanced stage. An increase in
      muscle mass and strength leads to an increase in physical activity, physical capability as
      well as tolerance to and applicability of tumor therapy. In the course of a 3-months
      intervention study the efficacy of a combined protein-rich nutritional therapy with an
      innovative exercise therapy will be documented for patients with esophageal and bronchial
      carcinoma in advanced or metastatic stage. An effective stopping of the progress of muscle
      wasting or even increase of muscle mass, strength and function in the patients of the trial
      would benefit each patient and his family individually, since it could mean a considerable
      improvement in his quality of life and tolerability of oncological treatment.
allocation: Non-Randomized
intervention model: Parallel Assignment
intervention model description: Prospective, controlled pilot study
primary purpose: Supportive Care
masking: Single (Outcomes Assessor)
masking description: The patients will be coded by a consecutive numbering. Data will be saved only with this number. Access to the data will only be provided to authorized personnel (study nurses) and will be retained in inaccessable and locked rooms.
measure: Muscle mass maintenance or increase, as assessed by Bioelectrical Impedance Analysis
time frame: 12 weeks per patient
description: Maintenance or increase of skeletal muscle mass in patients with esophagus or bronchial carcinoma receiving a combined therapy of protein-rich nutrition and WB-EMS, by assessing Bioelectrical Impedance Analysis values.
measure: Increase in quality of life score by assessing the score points using EORTC-QLQ-C30 questionnaires
time frame: 12 weeks per patient
description: Clinical improvement by an increase in quality of life in patients with esophagus or bronchial carcinoma receiving a combined therapy of protein-rich nutrition and WB-EMS.
measure: Increase or maintenance of muscle strength, as assessed by hand grip strength measurements (Jamar dynamometry)
time frame: 12 weeks per patient
description: Clinical improvement by an increase in muscle strength in patients with esophagus or bronchial carcinoma receiving a combined therapy of protein-rich nutrition and WB-EMS.
measure: Improvement of pain scores, as assessed by Visual Analog Score
time frame: 12 weeks per patient
description: Clinical improvement by an increase of pain scores in patients with esophagus or bronchial carcinoma receiving a combined therapy of protein-rich nutrition and WB-EMS.
measure: Improvement of fatigue scores, as assessed by FACIT-Fatigue Score
time frame: 12 weeks per patient
description: Clinical improvement by an increase of fatigue scores in patients with esophagus or bronchial carcinoma receiving a combined therapy of protein-rich nutrition and WB-EMS.
measure: Improvement of oncological therapy tolerance, as assessed by Common Toxicity Criteria regarding gastrointestinal complaints
time frame: 12 weeks per patient
description: Clinical improvement oncology therapy tolerance in patients with esophagus or bronchial carcinoma receiving a combined therapy of protein-rich nutrition and WB-EMS.
measure: Maintenance or increase in Body Mass Index (BMI) in kg/m^2-analysis (combination of weight in kilograms and height and in meters
time frame: 12 weeks per patient
description: Maintenance or increase of skeletal muscle mass in patients with esophagus or bronchial carcinoma receiving a combined therapy of protein-rich nutrition and WB-EMS, by assessing BMI in kg/m^2 (combination of weight in kilograms and height in meters).
arm group label: Control
arm group type: Active Comparator
description: Group of patients receiving individualized protein-rich nutritional therapy without exercise, 12 weeks intervention per patient
arm group label: EMS-group
arm group type: Experimental
description: Group of patients receiving individualized protein-rich nutritional therapy with personalized whole body electromyostimulation exercise, 12 weeks intervention per patient
intervention type: Procedure
intervention name: whole body electromyostimulation exercise
description: whole body electromyostimulation exercise training twice a week for 20 min each, bipolar, 85 Hz, intermittent pulse/pause, pulse width 350 µsec
arm group label: EMS-group
intervention type: Procedure
intervention name: protein-rich nutrition therapy
description: protein-rich nutrition therapy with an objective of reaching 1,2 to 1,5 g protein/kg body weight and day
arm group label: Control
arm group label: EMS-group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Yurdaguel Zopf, Prof.
role: Principal Investigator
affiliation: University Erlangen Nuremberg Medical School
last name: Yurdaguel Zopf, Prof.
phone: *49 9131 85-35000
email: yurdaguel.zopf@uk-erlangen.de
facility: 
status: Recruiting
contact: 
country: Germany
responsible party type: Sponsor
mesh term: Lung Neoplasms
mesh term: Esophageal Neoplasms
mesh term: Carcinoma, Bronchogenic
sharing ipd: No