An interventional study of Whole-Body Electromyostimulation (WB-EMS) in Gynecologic Cancer and Cachexia, sponsored by University of Erlangen-Nürnberg Medical School. Status unknown at 1 site in Germany. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-06-26.
Sponsored by University of Erlangen-Nürnberg Medical School · Not applicable, Interventional, and Supportive care
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, quality of life, fatigue and Inflammatory status on patients with gynecological cancer undergoing palliative anti-cancer Treatment. Furthermore, this study assesses the effect of this combined therapeutic approach within a 3 to 4-week pre-operative study Intervention on the period of hospitalization in gynecological patients undergoing curative anti-cancer Treatment.
196 studies on the registry are indexed under Wasting Syndrome; 22 are open to participants now.
This study's planned enrollment of 150 is above the median of 58 across 130 interventional studies indexed under Wasting Syndrome.
Browse Wasting Syndrome studies →University of Erlangen-Nürnberg Medical School is the lead sponsor of 267 studies on the registry; 51 are open to participants now.
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Exclusion Criteria:
"usual care" control group (includes patients undergoing palliative Treatment) receives individualized nutritional support (dietary advices: daily protein intake1,2 - 1,5 g/kg bodyweight)
physical exercise group (includes patients undergoing palliative Treatment) receives regular WB-EMS training (2 EMS trainings per week; each session for 20 min) + individualized nutritional support (dietary advices: daily protein intake 1,2-1,5 g/kg bodyweight)
Other: Whole-Body Electromyostimulation (WB-EMS)
"usual care" control group (includes patients undergoing curative treatment 3-4 weeks before surgery) receives individualized nutritional support (dietary advices: daily protein intake1,2 - 1,5 g/kg bodyweight)
physical exercise group (includes patients undergoing adjuvant treatment 3-4 weeks before surgery) receives regular WB-EMS training (2 EMS trainings per week; each session for 20 min) + individualized nutritional support (dietary advices: daily protein intake 1,2-1,5 g/kg bodyweight)
Other: 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
Change in Skeletal muscle mass
Skeletal muscle mass assessed by bioelectrical impedance analysis (in kg)
Time frame: 12 weeks (palliative treatment), 3-4 weeks (curative treatment)
Period of hospitalization
Days of Hospital stay after curative surgery
Time frame: 3-4 week (curative treatment)
Physical function - Isometric muscle strength
Hand grip strength assessed by hand dynamometer (in kg)
Time frame: 12 weeks (palliative treatment), 3-4 weeks (curative treatment)
Physical function - Endurance
Six-minute-walk test (walking distance in m)
Time frame: 12 weeks (palliative treatment), 3-4 weeks (curative treatment)
Physical function - Lower limb strength
30 second sit-to-stand test (number of sit-to-stand cycles)
Time frame: 12 weeks (palliative treatment), 3-4 weeks (curative treatment)
Patient-reported performance status
Karnofsky index
Time frame: 12 weeks (palliative treatment), 3-4 weeks (curative treatment), Total Score ranges from 0-100 with a higher score indicating better performance status
Patient-reported Quality of Life (QoL)
European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ - C30); Total score ranges from 0-100 with a higher score indicating better functioning/Quality of life or higher symptom burden
Time frame: 12 weeks (palliative treatment), 3-4 weeks (curative treatment)
Patient-reported Fatigue
FACIT-Fatigue scale; Total score ranges from 0-52 with a higher score indicating better Quality of life/less fatigue
Time frame: 12 weeks (palliative treatment), 3-4 weeks (curative treatment)
Pain score
Visual Analogue Scale (VAS); Total score ranges from 0-10 with a higher score indicating higher pain
Time frame: 12 weeks (palliative treatment), 3-4 weeks (curative treatment)
Depression score
Beck Depression Inventory (BDI); Total score ranges from 0-63 with higher score indicating higher depression
Time frame: 12 weeks (palliative treatment), 3-4 weeks (curative treatment)
Gastrointestinal toxicity of chemotherapy
Number of participants with treatment-related adverse events of gastrointestinal toxicity as assessed by CTCAE v4.0
Time frame: 12 weeks (palliative treatment), 3-4 weeks (curative treatment)
Physical activity
International Physical Activity Questionnaire (IPAQ); Higher score indicates higher physical acitivity level
Time frame: 12 weeks (palliative treatment), 3-4 weeks (curative treatment)
Inflammatory status
Analysis of serum C-reactive protein (CRP) and albumin concentrations
Time frame: 12 weeks (palliative treatment), 3-4 weeks (curative treatment)
This study is status unknown, as verified in Jun 2018. You cannot join it, but the record below documents what was studied.
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University of Erlangen-Nürnberg Medical School