Effects of WB-EMS and Specific Dietary Supplements on Cancer Patients

Not Applicable

• Conditions: Weight Loss; Cancer Cachexia; Muscle Loss; Muscle Weakness; Cancer
• Interventions: Dietary Supplement: β-hydroxy-β-methylbutyrate (HMB); Dietary Supplement: L-carnitine (LC); Dietary Supplement: Eicosapentaenoic acid (EPA); Other: Whole-Body Electromyostimulation (WB-EMS)

• Registration Number: NCT03151291
• Lead Sponsor: University of Erlangen-Nürnberg Medical School

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-12
• Study First Submitted: 2017-05-11
• Study First Submitted QC: 2017-05-11
• Study First Posted: 2017-05-12
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-15
• Last Update Posted: 2018-10-16
• Primary Completion: 2019-03-31
• Study Completion: 2019-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HMB group	β-hydroxy-β-methylbutyrate (HMB)	HMB supplemented group receives individualized nutritional support (dietary advices: daily protein intake \> 1.0 g/kg bodyweight) + specific dietary supplementation with HMB (3 g/d)
HMB+EMS group	β-hydroxy-β-methylbutyrate (HMB)	HMB supplemented physical exercise group performing a regular WB-EMS Training (two WB-EMS trainings per week; each session for 20 min) + individualized nutritional support (dietary advices: daily protein intake \> 1.0 g/kg bodyweight) + specific dietary supplementation with HMB (3 g/d)
LC+EMS group	L-carnitine (LC)	LC supplemented physical exercise group performing a regular WB-EMS Training (two WB-EMS trainings per week; each session for 20 min) + individualized nutritional support (dietary advices: daily protein intake \> 1.0 g/kg bodyweight) + specific dietary supplementation with LC (4 g/d)
HMB+EMS group	Whole-Body Electromyostimulation (WB-EMS)	HMB supplemented physical exercise group performing a regular WB-EMS Training (two WB-EMS trainings per week; each session for 20 min) + individualized nutritional support (dietary advices: daily protein intake \> 1.0 g/kg bodyweight) + specific dietary supplementation with HMB (3 g/d)
LC group	L-carnitine (LC)	LC supplemented group receives individualized nutritional support (dietary advices: daily protein intake \> 1.0 g/kg bodyweight) + specific dietary supplementation with LC (4 g/d)
EPA group	Eicosapentaenoic acid (EPA)	EPA supplemented group receives individualized nutritional support (dietary advices: daily protein intake \> 1.0 g/kg bodyweight) + specific dietary supplementation with EPA (2.2 g/d)
EPA+EMS group	Eicosapentaenoic acid (EPA)	EPA supplemented physical exercise group performing a regular WB-EMS Training (two WB-EMS trainings per week; each session for 20 min) + individualized nutritional support (dietary advices: daily protein intake \> 1.0 g/kg bodyweight) + specific dietary supplementation with EPA (2.2 g/d)
EMS group	Whole-Body Electromyostimulation (WB-EMS)	physical exercise group performing a regular WB-EMS Training (two WB-EMS trainings per week; each session for 20 min) + individualized nutritional support (dietary advices: daily protein intake \> 1.0 g/kg bodyweight)
LC+EMS group	Whole-Body Electromyostimulation (WB-EMS)	LC supplemented physical exercise group performing a regular WB-EMS Training (two WB-EMS trainings per week; each session for 20 min) + individualized nutritional support (dietary advices: daily protein intake \> 1.0 g/kg bodyweight) + specific dietary supplementation with LC (4 g/d)
EPA+EMS group	Whole-Body Electromyostimulation (WB-EMS)	EPA supplemented physical exercise group performing a regular WB-EMS Training (two WB-EMS trainings per week; each session for 20 min) + individualized nutritional support (dietary advices: daily protein intake \> 1.0 g/kg bodyweight) + specific dietary supplementation with EPA (2.2 g/d)

Primary Outcome Measures

Name	Time	Method
Skeletal muscle mass	12 weeks	Skeletal muscle mass assessed by bioelectrical impedance analysis (in kg)

Secondary Outcome Measures

Name	Time	Method
Patient-reported Quality of Life (QoL)	12 weeks	EORTC QLQ - C30 questionnaire
Physical function - isometric muscle strength	12 weeks	Isometric 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
Inflammatory blood markers	12 weeks	Blood collection and analysis of e.g. C-reactive protein (CRP), Albumin

Trial Locations

Locations (1)

Hector-Center for Nutrition, Exercise and Sports; 🇩🇪 Erlangen, Bavaria, Germany