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CancerNCT02293239

Effects of WB-EMS and Dietetic Treatment on Cancer Patients

A study testing Whole-Body Electromyostimulation (WB-EMS) in people with Cancer and Cancer Cachexia, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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 Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cancer, Cancer Cachexia, Weight Loss
What is being tested?
Whole-Body Electromyostimulation (WB-EMS)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
278 participants
Where
1 siteGermany
Study dates
Aug 2013to Aug 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • energy active metals in body
  • pregnancy
  • acute vein thrombosis

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Medizinische Klinik 1, University of Erlangen-Nürnberg

    Erlangen, Bavaria / Franconia, 91054

Other trials in Germany

About this study

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

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

Being tested
Whole-Body Electromyostimulation (WB-EMS)
Keywords
whole-body electromyostimulation, cachexia, cancer, skeletal muscle mass, nutrition
Medical subject headings
Neoplasms, Weight Loss, Muscular Atrophy, Muscle Weakness, Cachexia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Whole-Body Electromyostimulation (WB-EMS)Other

    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

Study groups in NCT02293239
Study groupRoleWhat they receive
Control GroupNo intervention"usual care" control group receives individualized nutritional support (dietary advices: daily protein intake > 1.0 g/kg bodyweight)
WB-EMS groupExperimentalphysical 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)
Receives: Other: Whole-Body Electromyostimulation (WB-EMS)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Skeletal muscle mass

    Skeletal muscle mass assessed by bioelectrical impedance analysis (in kg)

    Measured: 12 weeks

  2. Physical function - Gait pattern

    Sensor-based gait analysis

    Measured: 12 weeks

Secondary outcomes (7)

  1. Physical function - Isometric muscle strength

    Hand grip strength assessed by hand dynamometer (in kg)

    Measured: 12 weeks

  2. Physical function - Endurance

    Six-minute-walk test (walking distance in m)

    Measured: 12 weeks

  3. Physical function - Lower limb strength

    30 second sit-to-stand test (number of sit-to-stand cycles)

    Measured: 12 weeks

  4. Patient-reported performance status

    ECOG performance status/Karnofsky index

    Measured: 12 weeks

  5. Patient-reported Quality of Life (QoL)

    EORTC QLQ - C30 questionnaire

    Measured: 12 weeks

  6. Patient-reported Fatigue

    FACIT-Fatigue scale

    Measured: 12 weeks

  7. Inflammatory blood markers

    Blood collection and analysis e.g. of C-reactive protein (CRP), Albumin

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Nov 2014 (estimated)
  2. Study startAug 2013
  3. Primary completionAug 2018
  4. Study completionAug 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
278 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02293239
Sponsor's protocol ID
EMS Tumor 01
Status last verified
Oct 2018
First submitted
13 Nov 2014
Last updated
16 Oct 2018
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 30618820

  • 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.

    PubMed 30208857

Questions about this trial

What is this clinical trial studying?

A study testing Whole-Body Electromyostimulation (WB-EMS) in people with Cancer and Cancer Cachexia, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Skeletal muscle mass (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02293239, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2018.

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