WB-EMS and Individualized Nutritional Support in Gynecological Cancer Patients

Study Overview
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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, 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.

Official Title
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Effect of Whole-body Electromyostimulation Combined With Individualized Nutritional Support on Patients With Gynecological Cancer Undergoing Curative and Palliative Treatment

Conditions
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Cachexia, Gynecologic Cancer

Intervention / Treatment
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* Other: Whole-Body Electromyostimulation (WB-EMS)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: female patients with gynecological cancer undergoing palliative or curative treatment 18 years and older ECOG status > 2 Exclusion Criteria: simultaneous participation in other nutritional or exercise intervention Trials or in the past 6 months 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 rheumatic diseases pregnant and nursing women psychiatric disorders with doubts about legal and cognitive capacity

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control group (palliative treatment)<br>usual care control group (includes patients undergoing palliative Treatment) receives individualized nutritional support (dietary advices: daily protein intake1,2 - 1,5 g/kg bodyweight) | |
| Experimental: WB-EMS group (palliative treatment)<br>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)<br>* 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<br>|
| No Intervention: Control group (curative treatment)<br>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) | |
| Experimental: WB-EMS group (curative treatment)<br>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)<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Skeletal muscle mass | Skeletal muscle mass assessed by bioelectrical impedance analysis (in kg) | 12 weeks (palliative treatment), 3-4 weeks (curative treatment) | 
| Period of hospitalization | Days of Hospital stay after curative surgery | 3-4 week (curative treatment) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical function - Isometric muscle strength | Hand grip strength assessed by hand dynamometer (in kg) | 12 weeks (palliative treatment), 3-4 weeks (curative treatment) | 
| Physical function - Endurance | Six-minute-walk test (walking distance in m) | 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) | 12 weeks (palliative treatment), 3-4 weeks (curative treatment) | 
| Patient-reported performance status | Karnofsky index | 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 | 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 | 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 | 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 | 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 | 12 weeks (palliative treatment), 3-4 weeks (curative treatment) | 
| Physical activity | International Physical Activity Questionnaire (IPAQ); Higher score indicates higher physical acitivity level | 12 weeks (palliative treatment), 3-4 weeks (curative treatment) | 
| Inflammatory status | Analysis of serum C-reactive protein (CRP) and albumin concentrations | 12 weeks (palliative treatment), 3-4 weeks (curative treatment) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cancer cachexia, gynecologic cancer, WB-EMS, whole-body electromyostimulation, nutrition, protein, exercise