Cancer, Cancer Cachexia, Weight Loss, Muscle Loss, Muscle Weakness
Conditions
Keywords
cancer cachexia, WB-EMS, skeletal muscle mass, exercise, nutrition, dietary supplements
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTL-carnitine (LC)
daily intake of 4 g LC
DIETARY_SUPPLEMENTEicosapentaenoic acid (EPA)
daily intake of 2.2 g EPA
DIETARY_SUPPLEMENTβ-hydroxy-β-methylbutyrate (HMB)
daily intake of 3 g HMB
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
Sponsors
University of Erlangen-Nürnberg Medical School
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Skeletal muscle mass | 12 weeks | Skeletal muscle mass assessed by bioelectrical impedance analysis (in kg) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Physical function - Endurance | 12 weeks | Six-minute-walk test (walking distance in m) |
| Physical function - Lower limb strength | 12 weeks | 30 second sit-to-stand test (number of sit-to-stand cycles) |
| Patient-reported performance status | 12 weeks | ECOG performance status/Karnofsky index |
| Physical function - isometric muscle strength | 12 weeks | Isometric hand grip strength assessed by hand Dynamometer (in kg) |
| Patient-reported Fatigue | 12 weeks | FACIT-Fatigue scale |
| Inflammatory blood markers | 12 weeks | Blood collection and analysis of e.g. C-reactive protein (CRP), Albumin |
| Patient-reported Quality of Life (QoL) | 12 weeks | EORTC QLQ - C30 questionnaire |
Countries
Germany
Contacts
Primary ContactYurdagül Zopf, Prof. Dr. med.
Backup ContactHans Joachim Herrmann, Dr. oec. troph.
Outcome results
None listed