Effects of WB-EMS and Dietetic Treatment on Cancer Patients

October 15, 2018 updated by: University of Erlangen-Nürnberg Medical School

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

278

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Bavaria / Franconia
      • Erlangen, Bavaria / Franconia, Germany, 91054
        • Medizinische Klinik 1, University of Erlangen-Nurnberg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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): 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

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: WB-EMS group

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)
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Skeletal muscle mass
Time Frame: 12 weeks
Skeletal muscle mass assessed by bioelectrical impedance analysis (in kg)
12 weeks
Physical function - Gait pattern
Time Frame: 12 weeks
Sensor-based gait analysis
12 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Erlangen-Nürnberg Medical School

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2013

Primary Completion (Actual)

August 1, 2018

Study Completion (Actual)

August 1, 2018

Study Registration Dates

First Submitted

November 13, 2014

First Submitted That Met QC Criteria

November 13, 2014

First Posted (Estimate)

November 18, 2014

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

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EMS Tumor 01

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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