Whole Body Electromyostimulation and Nutritional Therapy for Patients With Esophageal and Bronchial Carcinoma

Study Overview
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Brief Summary
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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
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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.

Official Title
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Influence of Whole Body Electromyostimulation and Nutritional Therapy for Patients With Esophageal and Bronchial Carcinoma in Curative and Palliative Treatment

Conditions
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Cancer of Esophagus, Cancer, Lung

Intervention / Treatment
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* Procedure: whole body electromyostimulation exercise
* Procedure: protein-rich nutrition therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective, controlled pilot study
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control<br>Group of patients receiving individualized protein-rich nutritional therapy without exercise, 12 weeks intervention per patient | Procedure: protein-rich nutrition therapy<br>* protein-rich nutrition therapy with an objective of reaching 1,2 to 1,5 g protein/kg body weight and day<br>|
| Experimental: EMS-group<br>Group of patients receiving individualized protein-rich nutritional therapy with personalized whole body electromyostimulation exercise, 12 weeks intervention per patient | Procedure: whole body electromyostimulation exercise<br>* whole body electromyostimulation exercise training twice a week for 20 min each, bipolar, 85 Hz, intermittent pulse/pause, pulse width 350 µsec<br>Procedure: protein-rich nutrition therapy<br>* protein-rich nutrition therapy with an objective of reaching 1,2 to 1,5 g protein/kg body weight and day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 12 weeks per patient | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 12 weeks per patient | 
| 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. | 12 weeks per patient | 
| 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. | 12 weeks per patient | 
| 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. | 12 weeks per patient | 
| 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. | 12 weeks per patient | 
| 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). | 12 weeks per patient |