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

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

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.

Study Overview

• Status: Unknown
• Conditions: Cancer; Muscle Weakness; Weight Loss; Cancer Cachexia; Muscle Loss
• Intervention / Treatment: Other: Whole-Body Electromyostimulation (WB-EMS); Dietary supplement: β-hydroxy-β-methylbutyrate (HMB); Dietary supplement: L-carnitine (LC); Dietary supplement: Eicosapentaenoic acid (EPA)

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yurdagül Zopf, Prof. Dr. med.; Phone Number: +49 9131 85-45218; Email: yurdaguel.zopf@uk-erlangen.de

Study Locations

• Germany
  • Bavaria
    • Erlangen, Bavaria, Germany, 91054
      • Recruiting
      • Hector-Center for Nutrition, Exercise and Sports
      • Contact: Yurdagül Zopf, Prof. Dr. med.; Phone Number: +49 9131 85-45218; Email: yurdaguel.zopf@k-erlangen.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

8

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group; "usual care" control group receives individualized nutritional support (dietary advices: daily protein intake > 1.0 g/kg bodyweight)
Experimental: EMS group; 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)	Other: Whole-Body Electromyostimulation (WB-EMS); 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
Experimental: HMB group; 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)	Dietary supplement: β-hydroxy-β-methylbutyrate (HMB); daily intake of 3 g HMB
Experimental: HMB+EMS group; 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)	Other: Whole-Body Electromyostimulation (WB-EMS); 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; Dietary supplement: β-hydroxy-β-methylbutyrate (HMB); daily intake of 3 g HMB
Experimental: LC group; 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)	Dietary supplement: L-carnitine (LC); daily intake of 4 g LC
Experimental: LC+EMS group; 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)	Other: Whole-Body Electromyostimulation (WB-EMS); 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; Dietary supplement: L-carnitine (LC); daily intake of 4 g LC
Experimental: EPA group; 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)	Dietary supplement: Eicosapentaenoic acid (EPA); daily intake of 2.2 g EPA
Experimental: EPA+EMS group; 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)	Other: Whole-Body Electromyostimulation (WB-EMS); 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; Dietary supplement: Eicosapentaenoic acid (EPA); daily intake of 2.2 g EPA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Skeletal muscle mass	Skeletal muscle mass assessed by bioelectrical impedance analysis (in kg)	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physical function - Endurance	Six-minute-walk test (walking distance in m)	12 weeks
Physical function - Lower limb strength	30 second sit-to-stand test (number of sit-to-stand cycles)	12 weeks
Patient-reported performance status	ECOG performance status/Karnofsky index	12 weeks
Patient-reported Quality of Life (QoL)	EORTC QLQ - C30 questionnaire	12 weeks
Patient-reported Fatigue	FACIT-Fatigue scale	12 weeks
Physical function - isometric muscle strength	Isometric hand grip strength assessed by hand Dynamometer (in kg)	12 weeks
Inflammatory blood markers	Blood collection and analysis of e.g. C-reactive protein (CRP), Albumin	12 weeks

Collaborators and Investigators

• Sponsor: University of Erlangen-Nürnberg Medical School

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2016
• Primary Completion (Anticipated): March 31, 2019
• Study Completion (Anticipated): April 1, 2019

Study Registration Dates

• First Submitted: May 11, 2017
• First Submitted That Met QC Criteria: May 11, 2017
• First Posted (Actual): May 12, 2017

Study Record Updates

• Last Update Posted (Actual): October 16, 2018
• Last Update Submitted That Met QC Criteria: October 15, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: exercise; nutrition; skeletal muscle mass; dietary supplements; cancer cachexia; WB-EMS
• Additional Relevant MeSH Terms: Pathologic Processes; Metabolic Diseases; Nervous System Diseases; Neurologic Manifestations; Nutrition Disorders; Body Weight; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Manifestations; Body Weight Changes; Emaciation; Muscle Weakness; Weight Loss; Wasting Syndrome; Cachexia
• Other Study ID Numbers: EMS and DS Tumor 01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No