Effects of WB-EMS and Specific Dietary Supplements on Cancer Patients

Study Overview
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Brief Summary
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Patients suffering from cancer often experience a loss of muscle mass and strength during disease and its therapy. Muscle wasting is the main characteristic of the so-called cancer cachexia syndrome and responsible for many therapy-related complications and a poorer prognosis of the patient. Stabilizing muscle mass should therefore be a great goal in cancer care. Physical exercise and nutrition are promising measures to combat cancer-related muscle atrophy but conventional exercise programs may not always be suitable for physical-weakened patients and increased catabolic processes are difficult to overcome by normal Nutrition - especially in advanced cancer. Therefore, the present study aims to test a combined approach of specific nutritional supplementation and exercise using the novel strength training method of Whole-Body electromyostimulation (WB-EMS). The study investigates the effect of a 12-week WB-EMS training combined with a dietary supplementation of β-hydroxy-β-methylbutyrate (HMB), L-carnitine (LC) or the omega-3-fatty acid eicosapentaenoic acid (EPA) on skeletal muscle mass, body composition, physical function, nutritional and inflammatory status, fatigue and quality of life in cancer patients undergoing oncological treatment. The results of this study may help to clarify the effectiveness of those combined interventions to counteract muscle wasting and other symptoms of cancer cachexia.

Official Title
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Effects of Physical Exercise in the Form of Whole-body Electromyostimulation (WB-EMS) Combined With Individualized Nutritional Therapy Using Specific Dietary Supplements on Cancer Patients 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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* Dietary Supplement: β-hydroxy-β-methylbutyrate (HMB)
* Dietary Supplement: L-carnitine (LC)
* Dietary Supplement: Eicosapentaenoic acid (EPA)
* 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) e.g. 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 ECOG Performance Status ≤ 2 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: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


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: EMS group<br>physical exercise group performing a regular WB-EMS Training (two WB-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>|
| Experimental: HMB group<br>HMB supplemented group receives individualized nutritional support (dietary advices: daily protein intake > 1.0 g/kg bodyweight) + specific dietary supplementation with HMB (3 g/d) | Dietary Supplement: β-hydroxy-β-methylbutyrate (HMB)<br>* daily intake of 3 g HMB<br>|
| Experimental: HMB+EMS group<br>HMB supplemented physical exercise group performing a regular WB-EMS Training (two WB-EMS trainings per week; each session for 20 min) + individualized nutritional support (dietary advices: daily protein intake > 1.0 g/kg bodyweight) + specific dietary supplementation with HMB (3 g/d) | Dietary Supplement: β-hydroxy-β-methylbutyrate (HMB)<br>* daily intake of 3 g HMB<br>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>|
| Experimental: LC group<br>LC supplemented group receives individualized nutritional support (dietary advices: daily protein intake > 1.0 g/kg bodyweight) + specific dietary supplementation with LC (4 g/d) | Dietary Supplement: L-carnitine (LC)<br>* daily intake of 4 g LC<br>|
| Experimental: LC+EMS group<br>LC supplemented physical exercise group performing a regular WB-EMS Training (two WB-EMS trainings per week; each session for 20 min) + individualized nutritional support (dietary advices: daily protein intake > 1.0 g/kg bodyweight) + specific dietary supplementation with LC (4 g/d) | Dietary Supplement: L-carnitine (LC)<br>* daily intake of 4 g LC<br>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>|
| Experimental: EPA group<br>EPA supplemented group receives individualized nutritional support (dietary advices: daily protein intake > 1.0 g/kg bodyweight) + specific dietary supplementation with EPA (2.2 g/d) | Dietary Supplement: Eicosapentaenoic acid (EPA)<br>* daily intake of 2.2 g EPA<br>|
| Experimental: EPA+EMS group<br>EPA supplemented physical exercise group performing a regular WB-EMS Training (two WB-EMS trainings per week; each session for 20 min) + individualized nutritional support (dietary advices: daily protein intake > 1.0 g/kg bodyweight) + specific dietary supplementation with EPA (2.2 g/d) | Dietary Supplement: Eicosapentaenoic acid (EPA)<br>* daily intake of 2.2 g EPA<br>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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical function - isometric muscle strength | Isometric 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 of e.g. 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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cancer cachexia, WB-EMS, skeletal muscle mass, exercise, nutrition, dietary supplements