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JOURNAL ONKOLOGIE – STUDIE

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

Rekrutierend

NCT-Nummer:
NCT03274349

Studienbeginn:
März 2017

Letztes Update:
16.10.2018

Wirkstoff:
-

Indikation (Clinical Trials):
Esophageal Neoplasms, Lung Neoplasms, Carcinoma, Bronchogenic

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
University of Erlangen-Nürnberg Medical School

Collaborator:
-

Studienleiter

Yurdaguel Zopf, Prof.
Principal Investigator
University Erlangen Nuremberg Medical School

Kontakt

Studienlocations
(1 von 1)

University Hospital Erlangen, Department of Medicine 1
91054 Erlangen
(Bayern)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Yurdaguel Zopf
Phone: +49 9131 85 35000
E-Mail: yurdaguel.zopf@uk-erlangen.de
» Ansprechpartner anzeigen

Studien-Informationen

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.

Ein-/Ausschlusskriterien

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

Studien-Rationale

Primary outcome:

1. Muscle mass maintenance or increase, as assessed by Bioelectrical Impedance Analysis (Time Frame - 12 weeks per patient):
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.



Secondary outcome:

1. Increase in quality of life score by assessing the score points using EORTC-QLQ-C30 questionnaires (Time Frame - 12 weeks per patient):
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.

2. Increase or maintenance of muscle strength, as assessed by hand grip strength measurements (Jamar dynamometry) (Time Frame - 12 weeks per patient):
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.

3. Improvement of pain scores, as assessed by Visual Analog Score (Time Frame - 12 weeks per patient):
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.

4. Improvement of fatigue scores, as assessed by FACIT-Fatigue Score (Time Frame - 12 weeks per patient):
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.

5. Improvement of oncological therapy tolerance, as assessed by Common Toxicity Criteria regarding gastrointestinal complaints (Time Frame - 12 weeks per patient):
Clinical improvement oncology therapy tolerance in patients with esophagus or bronchial carcinoma receiving a combined therapy of protein-rich nutrition and WB-EMS.

6. Maintenance or increase in Body Mass Index (BMI) in kg/m^2-analysis (combination of weight in kilograms and height and in meters (Time Frame - 12 weeks per patient):
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).

Studien-Arme

  • Active Comparator: Control
    Group of patients receiving individualized protein-rich nutritional therapy without exercise, 12 weeks intervention per patient
  • Experimental: EMS-group
    Group of patients receiving individualized protein-rich nutritional therapy with personalized whole body electromyostimulation exercise, 12 weeks intervention per patient

Geprüfte Regime

  • 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

Quelle: ClinicalTrials.gov


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