Clinical Trials Directory

Trials / Unknown

UnknownNCT03274349

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

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

Status
Unknown
Phase
N/A
Study type
Interventional
Enrollment
150 (estimated)
Sponsor
University of Erlangen-Nürnberg Medical School · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
PROCEDUREwhole body electromyostimulation exercisewhole body electromyostimulation exercise training twice a week for 20 min each, bipolar, 85 Hz, intermittent pulse/pause, pulse width 350 µsec
PROCEDUREprotein-rich nutrition therapyprotein-rich nutrition therapy with an objective of reaching 1,2 to 1,5 g protein/kg body weight and day

Timeline

Start date
2017-03-17
Primary completion
2021-03-01
Completion
2021-03-01
First posted
2017-09-06
Last updated
2018-10-16

Locations

1 site across 1 country: Germany

Source: ClinicalTrials.gov record NCT03274349. Inclusion in this directory is not an endorsement.