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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
150
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
Department of Medicine 1, Hector Center for Nutrition, Exercise and Sports, Friedrich-Alexander-University Erlangen-Nuremberg
Erlangen, Germany
RECRUITINGChange 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)
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