Gynecologic Cancer, Cachexia
Conditions
Keywords
gynecologic cancer, WB-EMS, whole-body electromyostimulation, nutrition, protein, exercise, cancer cachexia
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.
Interventions
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
Sponsors
University of Erlangen-Nürnberg Medical School
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| Physical function - Isometric muscle strength | 12 weeks (palliative treatment), 3-4 weeks (curative treatment) | Hand grip strength assessed by hand dynamometer (in kg) |
| 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 |
| 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 activity | 12 weeks (palliative treatment), 3-4 weeks (curative treatment) | International Physical Activity Questionnaire (IPAQ); Higher score indicates higher physical acitivity level |
| Inflammatory status | 12 weeks (palliative treatment), 3-4 weeks (curative treatment) | Analysis of serum C-reactive protein (CRP) and albumin concentrations |
| 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 function - Endurance | 12 weeks (palliative treatment), 3-4 weeks (curative treatment) | Six-minute-walk test (walking distance in m) |
Countries
Germany
Contacts
Primary ContactYurdagül Zopf, Prof. Dr. med.
Backup ContactHans Joachim Herrmann, Dr. oec. troph.
Outcome results
None listed