Cancer, Cancer Cachexia, Weight Loss, Muscle Loss, Muscle Weakness
Conditions
Keywords
whole-body electromyostimulation, cachexia, cancer, skeletal muscle mass, nutrition
Brief summary
This study evaluates the effects of a 12-week whole-body electromyostimulation (WB-EMS) training combined with individualized nutritional support on body composition, muscle strength and function and quality of life of patients with malignant disease undergoing curative or palliative anti-cancer treatment
Interventions
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
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* malignant disease (solid or hematological cancer): 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 or Graft-versus-Host-Disease after bone marrow transplantation * ongoing or planned curative or palliative anti-cancer therapy
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) |
| Physical function - Gait pattern | 12 weeks | Sensor-based gait analysis |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Physical function - Isometric muscle strength | 12 weeks | Hand grip strength assessed by hand dynamometer (in kg) |
| 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 |
| Patient-reported Fatigue | 12 weeks | FACIT-Fatigue scale |
| Patient-reported Quality of Life (QoL) | 12 weeks | EORTC QLQ - C30 questionnaire |
| Inflammatory blood markers | 12 weeks | Blood collection and analysis e.g. of C-reactive protein (CRP), Albumin |
Countries
Germany
Outcome results
None listed