Effects of WB-EMS and Dietetic Treatment on Cancer Patients

NCT ID: NCT02293239

Last Updated: 2018-10-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

278 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-08-31

Study Completion Date

2018-08-31

Brief Summary

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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

Detailed Description

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Conditions

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Cancer Cancer Cachexia Weight Loss Muscle Loss Muscle Weakness

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Control Group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

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)

Group Type EXPERIMENTAL

Whole-Body Electromyostimulation (WB-EMS)

Intervention Type 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

Interventions

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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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Erlangen-Nürnberg Medical School

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Medizinische Klinik 1, University of Erlangen-Nürnberg

Erlangen, Bavaria / Franconia, Germany

Site Status

Countries

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Germany

References

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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.

Reference Type DERIVED
PMID: 30618820 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30208857 (View on PubMed)

Other Identifiers

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EMS Tumor 01

Identifier Type: -

Identifier Source: org_study_id

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