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Effects of WB-EMS and Dietetic Treatment on Cancer Patients

Primary Purpose

Cancer, Cancer Cachexia, Weight Loss

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Whole-Body Electromyostimulation (WB-EMS)
Sponsored by
University of Erlangen-Nürnberg Medical School
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cancer focused on measuring whole-body electromyostimulation, cachexia, cancer, skeletal muscle mass, nutrition

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Medizinische Klinik 1, University of Erlangen-Nürnberg

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control Group

WB-EMS group

Arm Description

"usual care" control group receives individualized nutritional support (dietary advices: daily protein intake > 1.0 g/kg bodyweight)

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)

Outcomes

Primary Outcome Measures

Skeletal muscle mass
Skeletal muscle mass assessed by bioelectrical impedance analysis (in kg)
Physical function - Gait pattern
Sensor-based gait analysis

Secondary Outcome Measures

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

Full Information

First Posted
November 13, 2014
Last Updated
October 15, 2018
Sponsor
University of Erlangen-Nürnberg Medical School
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1. Study Identification

Unique Protocol Identification Number
NCT02293239
Brief Title
Effects of WB-EMS and Dietetic Treatment on Cancer Patients
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
August 2013 (Actual)
Primary Completion Date
August 2018 (Actual)
Study Completion Date
August 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Erlangen-Nürnberg Medical School

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer, Cancer Cachexia, Weight Loss, Muscle Loss, Muscle Weakness
Keywords
whole-body electromyostimulation, cachexia, cancer, skeletal muscle mass, nutrition

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
278 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control Group
Arm Type
No Intervention
Arm Description
"usual care" control group receives individualized nutritional support (dietary advices: daily protein intake > 1.0 g/kg bodyweight)
Arm Title
WB-EMS group
Arm Type
Experimental
Arm Description
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)
Intervention Type
Other
Intervention Name(s)
Whole-Body Electromyostimulation (WB-EMS)
Intervention Description
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
Primary Outcome Measure Information:
Title
Skeletal muscle mass
Description
Skeletal muscle mass assessed by bioelectrical impedance analysis (in kg)
Time Frame
12 weeks
Title
Physical function - Gait pattern
Description
Sensor-based gait analysis
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Physical function - Isometric muscle strength
Description
Hand grip strength assessed by hand dynamometer (in kg)
Time Frame
12 weeks
Title
Physical function - Endurance
Description
Six-minute-walk test (walking distance in m)
Time Frame
12 weeks
Title
Physical function - Lower limb strength
Description
30 second sit-to-stand test (number of sit-to-stand cycles)
Time Frame
12 weeks
Title
Patient-reported performance status
Description
ECOG performance status/Karnofsky index
Time Frame
12 weeks
Title
Patient-reported Quality of Life (QoL)
Description
EORTC QLQ - C30 questionnaire
Time Frame
12 weeks
Title
Patient-reported Fatigue
Description
FACIT-Fatigue scale
Time Frame
12 weeks
Title
Inflammatory blood markers
Description
Blood collection and analysis e.g. of C-reactive protein (CRP), Albumin
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Medizinische Klinik 1, University of Erlangen-Nürnberg
City
Erlangen
State/Province
Bavaria / Franconia
ZIP/Postal Code
91054
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
30618820
Citation
Schink K, Reljic D, Herrmann HJ, Meyer J, Mackensen A, Neurath MF, Zopf Y. Whole-Body Electromyostimulation Combined With Individualized Nutritional Support Improves Body Composition in Patients With Hematological Malignancies - A Pilot Study. Front Physiol. 2018 Dec 18;9:1808. doi: 10.3389/fphys.2018.01808. eCollection 2018.
Results Reference
derived
PubMed Identifier
30208857
Citation
Schink K, Herrmann HJ, Schwappacher R, Meyer J, Orlemann T, Waldmann E, Wullich B, Kahlmeyer A, Fietkau R, Lubgan D, Beckmann MW, Hack C, Kemmler W, Siebler J, Neurath MF, Zopf Y. Effects of whole-body electromyostimulation combined with individualized nutritional support on body composition in patients with advanced cancer: a controlled pilot trial. BMC Cancer. 2018 Sep 12;18(1):886. doi: 10.1186/s12885-018-4790-y.
Results Reference
derived

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Effects of WB-EMS and Dietetic Treatment on Cancer Patients

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