跳至主要内容
临床试验/NCT03274349
NCT03274349Unknown不适用

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

University of Erlangen-Nürnberg Medical School2 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2017年3月17日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
150
试验地点
2
主要终点
Muscle mass maintenance or increase, as assessed by Bioelectrical Impedance Analysis

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Outcomes Assessor)

盲法说明

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.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with esophageal and/or bronchial carcinoma in curative or palliative treatment

排除标准

  • 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
  • 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

研究组 & 干预措施

Control

Active Comparator

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

干预措施: protein-rich nutrition therapy (Procedure)

EMS-group

Experimental

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

干预措施: whole body electromyostimulation exercise (Procedure)

EMS-group

Experimental

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

干预措施: protein-rich nutrition therapy (Procedure)

结局指标

主要结局

Muscle mass maintenance or increase, as assessed by Bioelectrical Impedance Analysis

时间窗: 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.

次要结局

  • Improvement of pain scores, as assessed by Visual Analog Score(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(12 weeks per patient)
  • Increase in quality of life score by assessing the score points using EORTC-QLQ-C30 questionnaires(12 weeks per patient)
  • Increase or maintenance of muscle strength, as assessed by hand grip strength measurements (Jamar dynamometry)(12 weeks per patient)
  • Improvement of oncological therapy tolerance, as assessed by Common Toxicity Criteria regarding gastrointestinal complaints(12 weeks per patient)
  • Improvement of fatigue scores, as assessed by FACIT-Fatigue Score(12 weeks per patient)

研究者

发起方
University of Erlangen-Nürnberg Medical School
申办方类型
Other
责任方
Sponsor

研究点 (2)

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