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

University of Erlangen-Nürnberg Medical School

Status: Unknown

Conditions: Weight Loss; Muscle Weakness; Cancer Cachexia; Cancer; Muscle Loss

Treatments: Dietary Supplement: L-carnitine (LC); Dietary Supplement: β-hydroxy-β-methylbutyrate (HMB); Other: Whole-Body Electromyostimulation (WB-EMS); Dietary Supplement: Eicosapentaenoic acid (EPA)

Study type: Interventional

Funder types: Other

Identifiers

NCT03151291

EMS and DS Tumor 01

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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200 participants in 8 patient groups

Control group

No Intervention group

Description:

"usual care" control group receives individualized nutritional support (dietary advices: daily protein intake \> 1.0 g/kg bodyweight)

EMS group

Experimental group

Description:

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)

Treatment:

Other: Whole-Body Electromyostimulation (WB-EMS)

HMB group

Experimental group

Description:

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)

Treatment:

Dietary Supplement: β-hydroxy-β-methylbutyrate (HMB)

HMB+EMS group

Experimental group

Description:

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)

Treatment:

Dietary Supplement: β-hydroxy-β-methylbutyrate (HMB)

Other: Whole-Body Electromyostimulation (WB-EMS)

LC group

Experimental group

Description:

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)

Treatment:

Dietary Supplement: L-carnitine (LC)

LC+EMS group

Experimental group

Description:

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)

Treatment:

Dietary Supplement: L-carnitine (LC)

Other: Whole-Body Electromyostimulation (WB-EMS)

EPA group

Experimental group

Description:

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)

Treatment:

Dietary Supplement: Eicosapentaenoic acid (EPA)

EPA+EMS group

Experimental group

Description:

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)

Treatment:

Dietary Supplement: Eicosapentaenoic acid (EPA)

Other: Whole-Body Electromyostimulation (WB-EMS)