Effects of WB-EMS and Dietetic Treatment on Cancer Patients

Not Applicable

Completed

• Conditions: Muscle Loss; Cancer Cachexia; Cancer; Weight Loss; Muscle Weakness
• Interventions: Other: Whole-Body Electromyostimulation (WB-EMS)

• Registration Number: NCT02293239
• Lead Sponsor: University of Erlangen-Nürnberg Medical School

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

Detailed Description

Not available

Study Timeline

• Study Start: 2013-08
• Study First Submitted: 2014-11-13
• Study First Submitted QC: 2014-11-13
• Study First Posted: 2014-11-18
• Primary Completion: 2018-08
• Study Completion: 2018-08
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-15
• Last Update Posted: 2018-10-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 278

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
WB-EMS group	Whole-Body Electromyostimulation (WB-EMS)	physical exercise group regular WB-EMS training (2 EMS trainings per week; each session for 20 min) + individualized nutritional support (dietary advices: daily protein intake \> 1.0 g/kg bodyweight)

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
Physical function - Endurance	12 weeks	Six-minute-walk test (walking distance in m)
Physical function - Isometric muscle strength	12 weeks	Hand grip strength assessed by hand dynamometer (in kg)
Physical function - Lower limb strength	12 weeks	30 second sit-to-stand test (number of sit-to-stand cycles)
Inflammatory blood markers	12 weeks	Blood collection and analysis e.g. of C-reactive protein (CRP), Albumin

Trial Locations

Locations (1)

Medizinische Klinik 1, University of Erlangen-Nürnberg; 🇩🇪 Erlangen, Bavaria / Franconia, Germany