Effects of WB-EMS and Dietetic Treatment on Cancer Patients

Study Overview
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Brief Summary
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This study evaluates the effects of a 12-week whole-body electromyostimulation (WB-EMS) training combined with individualized nutritional support on body composition, muscle strength and function and quality of life of patients with malignant disease undergoing curative or palliative anti-cancer treatment

Official Title
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Effects of Whole-Body Electromyostimulation (WB-EMS) Combined With Individualized Nutritional Support on Patients With Malignant Disease Undergoing Curative or Palliative Anti-cancer Treatment

Conditions
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Cancer, Cancer Cachexia, Weight Loss, Muscle Loss, Muscle Weakness

Intervention / Treatment
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* Other: Whole-Body Electromyostimulation (WB-EMS)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: malignant disease (solid or hematological cancer): head and neck cancer, colorectal carcinoma, small intestinal cancer, gastric cancer, oesophageal cancer, pancreas carcinoma, liver cell carcinoma, cholangiocarcinoma,lung cancer, breast cancer, cervix cancer, ovarian cancer, prostate cancer, renal cell carcinoma, malignant melanoma, patients with leukaemia and malignant lymphomas or Graft-versus-Host-Disease after bone marrow transplantation ongoing or planned curative or palliative anti-cancer therapy Exclusion Criteria: simultaneous participation in other nutritional or exercise intervention trials acute cardiovascular events use of anabolic medications epilepsy severe neurological diseases skin lesions in the area of electrodes energy active metals in body pregnancy acute vein thrombosis

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control Group<br>usual care control group receives individualized nutritional support (dietary advices: daily protein intake > 1.0 g/kg bodyweight) | |
| Experimental: WB-EMS group<br>physical exercise group regular WB-EMS training (2 EMS trainings per week; each session for 20 min) + individualized nutritional support (dietary advices: daily protein intake > 1.0 g/kg bodyweight) | Other: Whole-Body Electromyostimulation (WB-EMS)<br>* WB-EMS training is performed 2x/week for 12 weeks; Stimulation protocol: Frequency of 85 Hz, pulse duration of 0.35 ms, stimulation period of 6 sec, resting period of 4 sec; supervised by certified training instructors/physiotherapists participants perform simple exercises during the stimulation period following a video tutorial<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Skeletal muscle mass | Skeletal muscle mass assessed by bioelectrical impedance analysis (in kg) | 12 weeks | 
| Physical function - Gait pattern | Sensor-based gait analysis | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical function - Isometric muscle strength | Hand grip strength assessed by hand dynamometer (in kg) | 12 weeks | 
| Physical function - Endurance | Six-minute-walk test (walking distance in m) | 12 weeks | 
| Physical function - Lower limb strength | 30 second sit-to-stand test (number of sit-to-stand cycles) | 12 weeks | 
| Patient-reported performance status | ECOG performance status/Karnofsky index | 12 weeks | 
| Patient-reported Quality of Life (QoL) | EORTC QLQ - C30 questionnaire | 12 weeks | 
| Patient-reported Fatigue | FACIT-Fatigue scale | 12 weeks | 
| Inflammatory blood markers | Blood collection and analysis e.g. of C-reactive protein (CRP), Albumin | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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whole-body electromyostimulation, cachexia, cancer, skeletal muscle mass, nutrition