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

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.

Study Overview

• Status: Unknown
• Conditions: Cancer, Lung; Cancer of Esophagus
• Intervention / Treatment: Procedure: protein-rich nutrition therapy; Procedure: whole body electromyostimulation exercise

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.

• Study Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yurdaguel Zopf, Prof.; Phone Number: *49 9131 85-35000; Email: yurdaguel.zopf@uk-erlangen.de

Study Locations

• Germany
  • Bavaria
    • Erlangen, Bavaria, Germany, 91054
      • Recruiting
      • University Hospital Erlangen, Department of Medicine 1
      • Contact: Yurdaguel Zopf; Phone Number: +49 9131 85 35000; Email: yurdaguel.zopf@uk-erlangen.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Erlangen-Nürnberg Medical School

Study record dates

Study Major Dates

• Study Start (Actual): March 17, 2017
• Primary Completion (Anticipated): March 1, 2021
• Study Completion (Anticipated): March 1, 2021

Study Registration Dates

• First Submitted: May 30, 2017
• First Submitted That Met QC Criteria: September 4, 2017
• First Posted (Actual): September 6, 2017

Study Record Updates

• Last Update Posted (Actual): October 16, 2018
• Last Update Submitted That Met QC Criteria: October 15, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Bronchial Neoplasms; Head and Neck Neoplasms; Esophageal Diseases; Lung Neoplasms; Esophageal Neoplasms; Carcinoma, Bronchogenic
• Other Study ID Numbers: EMS Nutr ÖsoBroCA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No