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Completed

NCT Number: NCT02293239

Effects of WB-EMS and Dietetic Treatment on Cancer Patients

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

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Key information

Conditions

Cancer Atrophy Body Weight Body Weight Changes Cachexia Cancer Cachexia Muscle Loss Muscle Weakness Muscular Atrophy Muscular Diseases Musculoskeletal Diseases Neoplasms Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Signs and Symptoms Thinness Weight Loss

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medizinische Klinik 1, University of Erlangen-Nürnberg

Erlangen, Bavaria / Franconia, 91054, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Skeletal muscle mass

    Time frame: 12 weeks

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

  2. Physical function - Gait pattern

    Time frame: 12 weeks

    Sensor-based gait analysis

Secondary outcomes

  1. Physical function - Isometric muscle strength

    Time frame: 12 weeks

    Hand grip strength assessed by hand dynamometer (in kg)

  2. Physical function - Endurance

    Time frame: 12 weeks

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

  3. Physical function - Lower limb strength

    Time frame: 12 weeks

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

  4. Patient-reported performance status

    Time frame: 12 weeks

    ECOG performance status/Karnofsky index

  5. Patient-reported Quality of Life (QoL)

    Time frame: 12 weeks

    EORTC QLQ - C30 questionnaire

  6. Patient-reported Fatigue

    Time frame: 12 weeks

    FACIT-Fatigue scale

  7. Inflammatory blood markers

    Time frame: 12 weeks

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

Sponsors and collaborators

Lead sponsor

University of Erlangen-Nürnberg Medical School

Other

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2018
Study completion
2018
First posted
Nov 18, 2014
Registry last updated
Oct 16, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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