WB-EMS and Individualized Nutritional Support in Gynecological Cancer Patients
- Conditions
- CachexiaGynecologic Cancer
- Interventions
- Other: Whole-Body Electromyostimulation (WB-EMS)
- Registration Number
- NCT03570242
- Lead Sponsor
- University of Erlangen-Nürnberg Medical School
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 150
- female patients with gynecological cancer undergoing palliative or curative treatment
- 18 years and older
- ECOG status > 2
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description WB-EMS group (curative treatment) Whole-Body Electromyostimulation (WB-EMS) 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) WB-EMS group (palliative treatment) Whole-Body Electromyostimulation (WB-EMS) 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)
- Primary Outcome Measures
Name Time Method Change in Skeletal muscle mass 12 weeks (palliative treatment), 3-4 weeks (curative treatment) Skeletal muscle mass assessed by bioelectrical impedance analysis (in kg)
Period of hospitalization 3-4 week (curative treatment) Days of Hospital stay after curative surgery
- Secondary Outcome Measures
Name Time Method Gastrointestinal toxicity of chemotherapy 12 weeks (palliative treatment), 3-4 weeks (curative treatment) Number of participants with treatment-related adverse events of gastrointestinal toxicity as assessed by CTCAE v4.0
Physical function - Endurance 12 weeks (palliative treatment), 3-4 weeks (curative treatment) Six-minute-walk test (walking distance in m)
Physical function - Isometric muscle strength 12 weeks (palliative treatment), 3-4 weeks (curative treatment) Hand grip strength assessed by hand dynamometer (in kg)
Physical function - Lower limb strength 12 weeks (palliative treatment), 3-4 weeks (curative treatment) 30 second sit-to-stand test (number of sit-to-stand cycles)
Patient-reported performance status 12 weeks (palliative treatment), 3-4 weeks (curative treatment), Total Score ranges from 0-100 with a higher score indicating better performance status Karnofsky index
Patient-reported Quality of Life (QoL) 12 weeks (palliative treatment), 3-4 weeks (curative treatment) 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
Pain score 12 weeks (palliative treatment), 3-4 weeks (curative treatment) Visual Analogue Scale (VAS); Total score ranges from 0-10 with a higher score indicating higher pain
Physical activity 12 weeks (palliative treatment), 3-4 weeks (curative treatment) International Physical Activity Questionnaire (IPAQ); Higher score indicates higher physical acitivity level
Patient-reported Fatigue 12 weeks (palliative treatment), 3-4 weeks (curative treatment) FACIT-Fatigue scale; Total score ranges from 0-52 with a higher score indicating better Quality of life/less fatigue
Depression score 12 weeks (palliative treatment), 3-4 weeks (curative treatment) Beck Depression Inventory (BDI); Total score ranges from 0-63 with higher score indicating higher depression
Inflammatory status 12 weeks (palliative treatment), 3-4 weeks (curative treatment) Analysis of serum C-reactive protein (CRP) and albumin concentrations
Trial Locations
- Locations (1)
Department of Medicine 1, Hector Center for Nutrition, Exercise and Sports, Friedrich-Alexander-University Erlangen-Nuremberg
🇩🇪Erlangen, Germany