Whole Body Electromyostimulation and Nutritional Therapy for Patients With Esophageal and Bronchial Carcinoma
Primary Purpose
Cancer of Esophagus, Cancer, Lung
Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
whole body electromyostimulation exercise
protein-rich nutrition therapy
Sponsored by
About this trial
This is an interventional supportive care trial for Cancer of Esophagus
Eligibility Criteria
Inclusion Criteria:
- Patients with esophageal and/or bronchial carcinoma in curative or palliative treatment
Exclusion Criteria:
- Healthy persons or patients under age
- Pregnancy, Lactation
- Psychological disorders, epilepsia, sever neurological disorders
- Participation in other exercise- or nutrition studies within the last 6 months
- Acute cardiovascular disease
- Rheuma
- Intake of anabolic drugs,
- Skin injuries in the area of electrode placements
- Electronic implants (defibrillator, pacemaker)
- Persons in mental hospitals by order of authorities or jurisdiction
Sites / Locations
- University Hospital Erlangen, Department of Medicine 1Recruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Control
EMS-group
Arm Description
Group of patients receiving individualized protein-rich nutritional therapy without exercise, 12 weeks intervention per patient
Group of patients receiving individualized protein-rich nutritional therapy with personalized whole body electromyostimulation exercise, 12 weeks intervention per patient
Outcomes
Primary Outcome Measures
Muscle mass maintenance or increase, as assessed by Bioelectrical Impedance Analysis
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.
Secondary Outcome Measures
Increase in quality of life score by assessing the score points using EORTC-QLQ-C30 questionnaires
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.
Increase or maintenance of muscle strength, as assessed by hand grip strength measurements (Jamar dynamometry)
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.
Improvement of pain scores, as assessed by Visual Analog Score
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.
Improvement of fatigue scores, as assessed by FACIT-Fatigue Score
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.
Improvement of oncological therapy tolerance, as assessed by Common Toxicity Criteria regarding gastrointestinal complaints
Clinical improvement oncology therapy tolerance in patients with esophagus or bronchial carcinoma receiving a combined therapy of protein-rich nutrition and WB-EMS.
Maintenance or increase in Body Mass Index (BMI) in kg/m^2-analysis (combination of weight in kilograms and height and in meters
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).
Full Information
NCT ID
NCT03274349
First Posted
May 30, 2017
Last Updated
October 15, 2018
Sponsor
University of Erlangen-Nürnberg Medical School
1. Study Identification
Unique Protocol Identification Number
NCT03274349
Brief Title
Whole Body Electromyostimulation and Nutritional Therapy for Patients With Esophageal and Bronchial Carcinoma
Official Title
Influence of Whole Body Electromyostimulation and Nutritional Therapy for Patients With Esophageal and Bronchial Carcinoma in Curative and Palliative Treatment
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Unknown status
Study Start Date
March 17, 2017 (Actual)
Primary Completion Date
March 2021 (Anticipated)
Study Completion Date
March 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Erlangen-Nürnberg Medical School
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer of Esophagus, Cancer, Lung
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Prospective, controlled pilot study
Masking
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.
Allocation
Non-Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Group of patients receiving individualized protein-rich nutritional therapy without exercise, 12 weeks intervention per patient
Arm Title
EMS-group
Arm Type
Experimental
Arm 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(s)
whole body electromyostimulation exercise
Intervention Description
whole body electromyostimulation exercise training twice a week for 20 min each, bipolar, 85 Hz, intermittent pulse/pause, pulse width 350 µsec
Intervention Type
Procedure
Intervention Name(s)
protein-rich nutrition therapy
Intervention Description
protein-rich nutrition therapy with an objective of reaching 1,2 to 1,5 g protein/kg body weight and day
Primary Outcome Measure Information:
Title
Muscle mass maintenance or increase, as assessed by Bioelectrical Impedance Analysis
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.
Time Frame
12 weeks per patient
Secondary Outcome Measure Information:
Title
Increase in quality of life score by assessing the score points using EORTC-QLQ-C30 questionnaires
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.
Time Frame
12 weeks per patient
Title
Increase or maintenance of muscle strength, as assessed by hand grip strength measurements (Jamar dynamometry)
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.
Time Frame
12 weeks per patient
Title
Improvement of pain scores, as assessed by Visual Analog Score
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.
Time Frame
12 weeks per patient
Title
Improvement of fatigue scores, as assessed by FACIT-Fatigue Score
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.
Time Frame
12 weeks per patient
Title
Improvement of oncological therapy tolerance, as assessed by Common Toxicity Criteria regarding gastrointestinal complaints
Description
Clinical improvement oncology therapy tolerance in patients with esophagus or bronchial carcinoma receiving a combined therapy of protein-rich nutrition and WB-EMS.
Time Frame
12 weeks per patient
Title
Maintenance or increase in Body Mass Index (BMI) in kg/m^2-analysis (combination of weight in kilograms and height and in meters
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).
Time Frame
12 weeks per patient
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with esophageal and/or bronchial carcinoma in curative or palliative treatment
Exclusion Criteria:
Healthy persons or patients under age
Pregnancy, Lactation
Psychological disorders, epilepsia, sever neurological disorders
Participation in other exercise- or nutrition studies within the last 6 months
Acute cardiovascular disease
Rheuma
Intake of anabolic drugs,
Skin injuries in the area of electrode placements
Electronic implants (defibrillator, pacemaker)
Persons in mental hospitals by order of authorities or jurisdiction
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yurdaguel Zopf, Prof.
Phone
*49 9131 85-35000
Email
yurdaguel.zopf@uk-erlangen.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yurdaguel Zopf, Prof.
Organizational Affiliation
University Erlangen Nuremberg Medical School
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Erlangen, Department of Medicine 1
City
Erlangen
State/Province
Bavaria
ZIP/Postal Code
91054
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yurdaguel Zopf
Phone
+49 9131 85 35000
Email
yurdaguel.zopf@uk-erlangen.de
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Whole Body Electromyostimulation and Nutritional Therapy for Patients With Esophageal and Bronchial Carcinoma
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