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

University of Erlangen-Nürnberg Medical School

Status: Unknown

Conditions: Cancer, Lung; Cancer of Esophagus

Treatments: Procedure: whole body electromyostimulation exercise; Procedure: protein-rich nutrition therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT03274349

EMS Nutr ÖsoBroCA

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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150 participants in 2 patient groups

Control

Active Comparator group

Description:

Group of patients receiving individualized protein-rich nutritional therapy without exercise, 12 weeks intervention per patient

Treatment:

Procedure: protein-rich nutrition therapy

EMS-group

Experimental group

Description:

Group of patients receiving individualized protein-rich nutritional therapy with personalized whole body electromyostimulation exercise, 12 weeks intervention per patient

Treatment:

Procedure: whole body electromyostimulation exercise

Procedure: protein-rich nutrition therapy