Influence of Whole Body Electromyostimulation and Nutritional Therapy for Patients With Esophageal and Bronchial Carcinoma in Curative and Palliative Treatment
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cancer of Esophagus
- Sponsor
- University of Erlangen-Nürnberg Medical School
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- Muscle mass maintenance or increase, as assessed by Bioelectrical Impedance Analysis
- Last Updated
- 7 years ago
Overview
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.
Investigators
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
- •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
Outcomes
Primary Outcomes
Muscle mass maintenance or increase, as assessed by Bioelectrical Impedance Analysis
Time Frame: 12 weeks per patient
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 Outcomes
- Improvement of pain scores, as assessed by Visual Analog Score(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(12 weeks per patient)
- Increase in quality of life score by assessing the score points using EORTC-QLQ-C30 questionnaires(12 weeks per patient)
- Increase or maintenance of muscle strength, as assessed by hand grip strength measurements (Jamar dynamometry)(12 weeks per patient)
- Improvement of oncological therapy tolerance, as assessed by Common Toxicity Criteria regarding gastrointestinal complaints(12 weeks per patient)
- Improvement of fatigue scores, as assessed by FACIT-Fatigue Score(12 weeks per patient)