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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Enrollment
200
daily intake of 3 g HMB
daily intake of 4 g LC
daily intake of 2.2 g EPA
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
Hector-Center for Nutrition, Exercise and Sports
Erlangen, Bavaria, Germany
RECRUITINGSkeletal muscle mass
Skeletal muscle mass assessed by bioelectrical impedance analysis (in kg)
Time frame: 12 weeks
Physical function - isometric muscle strength
Isometric hand grip strength assessed by hand Dynamometer (in kg)
Time frame: 12 weeks
Physical function - Endurance
Six-minute-walk test (walking distance in m)
Time frame: 12 weeks
Physical function - Lower limb strength
30 second sit-to-stand test (number of sit-to-stand cycles)
Time frame: 12 weeks
Patient-reported performance status
ECOG performance status/Karnofsky index
Time frame: 12 weeks
Patient-reported Quality of Life (QoL)
EORTC QLQ - C30 questionnaire
Time frame: 12 weeks
Patient-reported Fatigue
FACIT-Fatigue scale
Time frame: 12 weeks
Inflammatory blood markers
Blood collection and analysis of e.g. C-reactive protein (CRP), Albumin
Time frame: 12 weeks
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