Effects of WB-EMS and Specific Dietary Supplements on Cancer Patients
October 15, 2018 updated by: University of Erlangen-Nürnberg Medical School
Effects of Physical Exercise in the Form of Whole-body Electromyostimulation (WB-EMS) Combined With Individualized Nutritional Therapy Using Specific Dietary Supplements on Cancer Patients Undergoing Curative or Palliative Anti-cancer Treatment
Patients suffering from cancer often experience a loss of muscle mass and strength during disease and its therapy.
Muscle wasting is the main characteristic of the so-called cancer cachexia syndrome and responsible for many therapy-related complications and a poorer prognosis of the patient.
Stabilizing muscle mass should therefore be a great goal in cancer care.
Physical exercise and nutrition are promising measures to combat cancer-related muscle atrophy but conventional exercise programs may not always be suitable for physical-weakened patients and increased catabolic processes are difficult to overcome by normal Nutrition - especially in advanced cancer.
Therefore, the present study aims to test a combined approach of specific nutritional supplementation and exercise using the novel strength training method of Whole-Body electromyostimulation (WB-EMS).
The study investigates the effect of a 12-week WB-EMS training combined with a dietary supplementation of β-hydroxy-β-methylbutyrate (HMB), L-carnitine (LC) or the omega-3-fatty acid eicosapentaenoic acid (EPA) on skeletal muscle mass, body composition, physical function, nutritional and inflammatory status, fatigue and quality of life in cancer patients undergoing oncological treatment.
The results of this study may help to clarify the effectiveness of those combined interventions to counteract muscle wasting and other symptoms of cancer cachexia.
Study Overview
Status
Unknown
Conditions
Study Type
Interventional
Enrollment (Anticipated)
200
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
-
-
Bavaria
-
Erlangen, Bavaria, Germany, 91054
- Recruiting
- Hector-Center for Nutrition, Exercise and Sports
-
Contact:
- Yurdagül Zopf, Prof. Dr. med.
- Phone Number: +49 9131 85-45218
- Email: yurdaguel.zopf@k-erlangen.de
-
-
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) e.g. 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
- ECOG Performance Status ≤ 2
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: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
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: EMS group
physical exercise group performing a regular WB-EMS Training (two WB-EMS trainings per week; each session for 20 min) + individualized nutritional support (dietary advices: daily protein intake > 1.0 g/kg bodyweight) |
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
|
|
Experimental: HMB group
HMB supplemented group receives individualized nutritional support (dietary advices: daily protein intake > 1.0 g/kg bodyweight) + specific dietary supplementation with HMB (3 g/d)
|
daily intake of 3 g HMB
|
|
Experimental: HMB+EMS group
HMB supplemented physical exercise group performing a regular WB-EMS Training (two WB-EMS trainings per week; each session for 20 min) + individualized nutritional support (dietary advices: daily protein intake > 1.0 g/kg bodyweight) + specific dietary supplementation with HMB (3 g/d) |
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
daily intake of 3 g HMB
|
|
Experimental: LC group
LC supplemented group receives individualized nutritional support (dietary advices: daily protein intake > 1.0 g/kg bodyweight) + specific dietary supplementation with LC (4 g/d)
|
daily intake of 4 g LC
|
|
Experimental: LC+EMS group
LC supplemented physical exercise group performing a regular WB-EMS Training (two WB-EMS trainings per week; each session for 20 min) + individualized nutritional support (dietary advices: daily protein intake > 1.0 g/kg bodyweight) + specific dietary supplementation with LC (4 g/d) |
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
daily intake of 4 g LC
|
|
Experimental: EPA group
EPA supplemented group receives individualized nutritional support (dietary advices: daily protein intake > 1.0 g/kg bodyweight) + specific dietary supplementation with EPA (2.2 g/d)
|
daily intake of 2.2 g EPA
|
|
Experimental: EPA+EMS group
EPA supplemented physical exercise group performing a regular WB-EMS Training (two WB-EMS trainings per week; each session for 20 min) + individualized nutritional support (dietary advices: daily protein intake > 1.0 g/kg bodyweight) + specific dietary supplementation with EPA (2.2 g/d) |
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
daily intake of 2.2 g EPA
|
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
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
|
Physical function - isometric muscle strength
Time Frame: 12 weeks
|
Isometric hand grip strength assessed by hand Dynamometer (in kg)
|
12 weeks
|
|
Inflammatory blood markers
Time Frame: 12 weeks
|
Blood collection and analysis of e.g.
C-reactive protein (CRP), Albumin
|
12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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)
December 1, 2016
Primary Completion (Anticipated)
March 31, 2019
Study Completion (Anticipated)
April 1, 2019
Study Registration Dates
First Submitted
May 11, 2017
First Submitted That Met QC Criteria
May 11, 2017
First Posted (Actual)
May 12, 2017
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- EMS and DS Tumor 01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
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.