Clinical trial NCT03151291: Effects of WB-EMS and Specific Dietary Supplements on Cancer Patients
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cancer
Cancer Cachexia
Weight Loss
Muscle Loss
Muscle Weakness
Keywords: cancer cachexia
WB-EMS
skeletal muscle mass
exercise
nutrition
dietary supplements
Lead sponsor: University of Erlangen-Nürnberg Medical School
Sponsor class: OTHER
First posted: 2017-05-12
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


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
* epilepsy
* severe neurological diseases
* skin lesions in the area of electrodes
* energy active metals in body
* pregnancy
* acute vein thrombosis

Primary outcomes:
measure: Skeletal muscle mass
timeFrame: 12 weeks
Secondary outcomes:
measure: Physical function - isometric muscle strength
timeFrame: 12 weeks
measure: Physical function - Endurance
timeFrame: 12 weeks
measure: Physical function - Lower limb strength
timeFrame: 12 weeks
measure: Patient-reported performance status
timeFrame: 12 weeks
measure: Patient-reported Quality of Life (QoL)
timeFrame: 12 weeks
measure: Patient-reported Fatigue
timeFrame: 12 weeks
measure: Inflammatory blood markers
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Erlangen
country: Germany
facility: Hector-Center for Nutrition, Exercise and Sports
state: Bavaria
Study officials:
References: