Effects of WB-EMS and Dietetic Treatment on Cancer Patients

Cancer Clinical Trial

Official title:

Effects of Whole-Body Electromyostimulation (WB-EMS) Combined With Individualized Nutritional Support on Patients With Malignant Disease Undergoing Curative or Palliative Anti-cancer Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02293239
• Other study ID #: EMS Tumor 01
• Status: Completed
• Phase: N/A
• Start date: August 2013
• Est. completion date: August 2018

Study information

• Verified date: October 2018
• Source: University of Erlangen-Nürnberg Medical School
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 278
• Est. completion date: August 2018
• Est. primary completion date: August 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cachexia
• Cancer
• Cancer Cachexia
• Muscle Loss
• Muscle Weakness
• Paresis
• Weight Loss

Intervention

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

Locations

Country	Name	City	State
Germany	Medizinische Klinik 1, University of Erlangen-Nürnberg	Erlangen	Bavaria / Franconia

Sponsors (1)

Lead Sponsor	Collaborator
University of Erlangen-Nürnberg Medical School

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Skeletal muscle mass	Skeletal muscle mass assessed by bioelectrical impedance analysis (in kg)	12 weeks
Primary	Physical function - Gait pattern	Sensor-based gait analysis	12 weeks
Secondary	Physical function - Isometric muscle strength	Hand grip strength assessed by hand dynamometer (in kg)	12 weeks
Secondary	Physical function - Endurance	Six-minute-walk test (walking distance in m)	12 weeks
Secondary	Physical function - Lower limb strength	30 second sit-to-stand test (number of sit-to-stand cycles)	12 weeks
Secondary	Patient-reported performance status	ECOG performance status/Karnofsky index	12 weeks
Secondary	Patient-reported Quality of Life (QoL)	EORTC QLQ - C30 questionnaire	12 weeks
Secondary	Patient-reported Fatigue	FACIT-Fatigue scale	12 weeks
Secondary	Inflammatory blood markers	Blood collection and analysis e.g. of C-reactive protein (CRP), Albumin	12 weeks