WB-EMS and Individualized Nutritional Support in Gynecological Cancer Patients
Effect of Whole-body Electromyostimulation Combined With Individualized Nutritional Support on Patients With Gynecological Cancer Undergoing Curative and Palliative Treatment
1 other identifier
interventional
150
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2017
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2017
CompletedFirst Submitted
Initial submission to the registry
June 1, 2018
CompletedFirst Posted
Study publicly available on registry
June 26, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2020
CompletedJune 26, 2018
June 1, 2018
3 years
June 1, 2018
June 25, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (11)
Physical function - Isometric muscle strength
12 weeks (palliative treatment), 3-4 weeks (curative treatment)
Physical function - Endurance
12 weeks (palliative treatment), 3-4 weeks (curative treatment)
Physical function - Lower limb strength
12 weeks (palliative treatment), 3-4 weeks (curative treatment)
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
Patient-reported Quality of Life (QoL)
12 weeks (palliative treatment), 3-4 weeks (curative treatment)
- +6 more secondary outcomes
Study Arms (4)
Control group (palliative treatment)
NO INTERVENTION"usual care" control group (includes patients undergoing palliative Treatment) receives individualized nutritional support (dietary advices: daily protein intake1,2 - 1,5 g/kg bodyweight)
WB-EMS group (palliative treatment)
EXPERIMENTALphysical 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)
Control group (curative treatment)
NO INTERVENTION"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)
WB-EMS group (curative treatment)
EXPERIMENTALphysical 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)
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
Eligibility Criteria
You may qualify if:
- female patients with gynecological cancer undergoing palliative or curative treatment
- years and older
- ECOG status \> 2
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Medicine 1, Hector Center for Nutrition, Exercise and Sports, Friedrich-Alexander-University Erlangen-Nuremberg
Erlangen, 91052, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 1, 2018
First Posted
June 26, 2018
Study Start
July 1, 2017
Primary Completion
June 30, 2020
Study Completion
June 30, 2020
Last Updated
June 26, 2018
Record last verified: 2018-06