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

NCT ID: NCT03274349

Last Updated: 2018-10-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-17

Study Completion Date

2021-03-31

Brief Summary

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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

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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

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Cancer of Esophagus Cancer, Lung

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Prospective, controlled pilot study
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors
The patients will be coded by a consecutive numbering. Data will be saved only with this number. Access to the data will only be provided to authorized personnel (study nurses) and will be retained in inaccessable and locked rooms.

Study Groups

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Control

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

Group Type ACTIVE_COMPARATOR

protein-rich nutrition therapy

Intervention Type PROCEDURE

protein-rich nutrition therapy with an objective of reaching 1,2 to 1,5 g protein/kg body weight and day

EMS-group

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

Group Type EXPERIMENTAL

whole body electromyostimulation exercise

Intervention Type PROCEDURE

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

Intervention Type PROCEDURE

protein-rich nutrition therapy with an objective of reaching 1,2 to 1,5 g protein/kg body weight and day

Interventions

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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

Intervention Type 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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Erlangen-Nürnberg Medical School

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yurdaguel Zopf, Prof.

Role: PRINCIPAL_INVESTIGATOR

University Erlangen Nuremberg Medical School

Locations

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University Hospital Erlangen, Department of Medicine 1

Erlangen, Bavaria, Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Yurdaguel Zopf, Prof.

Role: CONTACT

*49 9131 85-35000

Facility Contacts

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Yurdaguel Zopf

Role: primary

+49 9131 85 35000

Other Identifiers

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EMS Nutr ÖsoBroCA

Identifier Type: -

Identifier Source: org_study_id

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