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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cancer
- Sponsor
- University of Erlangen-Nürnberg Medical School
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- Skeletal muscle mass
- Last Updated
- 7 years ago
Overview
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.
Investigators
Eligibility Criteria
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
- •severe neurological diseases
- •skin lesions in the area of electrodes
- •energy active metals in body
- •pregnancy
- •acute vein thrombosis
Outcomes
Primary Outcomes
Skeletal muscle mass
Time Frame: 12 weeks
Skeletal muscle mass assessed by bioelectrical impedance analysis (in kg)
Secondary Outcomes
- Patient-reported Quality of Life (QoL)(12 weeks)
- Physical function - isometric muscle strength(12 weeks)
- Physical function - Endurance(12 weeks)
- Physical function - Lower limb strength(12 weeks)
- Patient-reported performance status(12 weeks)
- Patient-reported Fatigue(12 weeks)
- Inflammatory blood markers(12 weeks)