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
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
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
NCT ID
NCT02293239
First Posted
November 13, 2014
Last Updated
October 15, 2018
Sponsor
University of Erlangen-Nürnberg Medical School
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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