Clinical trial NCT03274349: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Cancer of Esophagus
Cancer, Lung
Lead sponsor: University of Erlangen-Nürnberg Medical School
Sponsor class: OTHER
First posted: 2017-09-06
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, controlled pilot study
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Muscle mass maintenance or increase, as assessed by Bioelectrical Impedance Analysis
timeFrame: 12 weeks per patient
Secondary outcomes:
measure: Increase in quality of life score by assessing the score points using EORTC-QLQ-C30 questionnaires
timeFrame: 12 weeks per patient
measure: Increase or maintenance of muscle strength, as assessed by hand grip strength measurements (Jamar dynamometry)
timeFrame: 12 weeks per patient
measure: Improvement of pain scores, as assessed by Visual Analog Score
timeFrame: 12 weeks per patient
measure: Improvement of fatigue scores, as assessed by FACIT-Fatigue Score
timeFrame: 12 weeks per patient
measure: Improvement of oncological therapy tolerance, as assessed by Common Toxicity Criteria regarding gastrointestinal complaints
timeFrame: 12 weeks per patient
measure: Maintenance or increase in Body Mass Index (BMI) in kg/m^2-analysis (combination of weight in kilograms and height and in meters
timeFrame: 12 weeks per patient
Other outcomes:
Locations:
city: Erlangen
country: Germany
facility: University Hospital Erlangen, Department of Medicine 1
state: Bavaria
Study officials:
affiliation: University Erlangen Nuremberg Medical School
name: Yurdaguel Zopf, Prof.
role: PRINCIPAL_INVESTIGATOR
References: