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

Cancer, Lung Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03274349
• Other study ID #: EMS Nutr ÖsoBroCA
• Status: Recruiting
• Phase: N/A
• Start date: March 17, 2017
• Est. completion date: March 2021

Study information

• Verified date: October 2018
• Source: University of Erlangen-Nürnberg Medical School
• Contact: Yurdaguel Zopf, Prof.
• Phone: *49 9131 85-35000
• Email: yurdaguel.zopf[@]uk-erlangen.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: March 2021
• Est. primary completion date: March 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer of Esophagus
• Cancer, Lung
• Carcinoma, Bronchogenic
• Esophageal Neoplasms
• Lung Neoplasms

Intervention

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
• 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

Locations

Country	Name	City	State
Germany	University Hospital Erlangen, Department of Medicine 1	Erlangen	Bavaria

Sponsors (1)

Lead Sponsor	Collaborator
University of Erlangen-Nürnberg Medical School

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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