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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | No Intervention | "usual care" control group receives individualized nutritional support (dietary advices: daily protein intake > 1.0 g/kg bodyweight) | |
| EMS group | Experimental | 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) |
|
| HMB group | Experimental | 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) |
|
| HMB+EMS group | Experimental | 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) |
|
| LC group | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| β-hydroxy-β-methylbutyrate (HMB) | Dietary Supplement | daily intake of 3 g HMB |
|
| Measure | Description | Time Frame |
|---|---|---|
| Skeletal muscle mass | Skeletal muscle mass assessed by bioelectrical impedance analysis (in kg) | 12 weeks |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yurdagül Zopf, Prof. Dr. med. | Contact | +49 9131 85-45218 | yurdaguel.zopf@uk-erlangen.de | |
| Hans Joachim Herrmann, Dr. oec. troph. | Contact | +49 9131 85-45017 | hans.herrmann@uk-erlangen.de |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hector-Center for Nutrition, Exercise and Sports | Recruiting | Erlangen | Bavaria | 91054 | Germany |
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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)
|
| LC+EMS group | Experimental | 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) |
|
| EPA group | Experimental | 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) |
|
| EPA+EMS group | Experimental | 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) |
|
| L-carnitine (LC) | Dietary Supplement | daily intake of 4 g LC |
|
| Eicosapentaenoic acid (EPA) | Dietary Supplement | daily intake of 2.2 g EPA |
|
| Whole-Body Electromyostimulation (WB-EMS) | Other | 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 |
|
| 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 |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D015431 | Weight Loss |
| D009133 | Muscular Atrophy |
| D018908 | Muscle Weakness |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D001284 | Atrophy |
| D020763 | Pathological Conditions, Anatomical |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D010335 | Pathologic Processes |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D002331 | Carnitine |
| D015118 | Eicosapentaenoic Acid |
| ID | Term |
|---|---|
| D050337 | Trimethyl Ammonium Compounds |
| D000644 | Quaternary Ammonium Compounds |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D015525 | Fatty Acids, Omega-3 |
| D004042 | Dietary Fats, Unsaturated |
| D004041 | Dietary Fats |
| D005223 | Fats |
| D008055 | Lipids |
| D015777 | Eicosanoids |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D005395 | Fish Oils |
| D009821 | Oils |
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