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

University of Erlangen-Nürnberg Medical School1 site in 1 country150 target enrollmentJuly 1, 2017

ConditionsGynecologic Cancer Cachexia

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Gynecologic Cancer
Sponsor: University of Erlangen-Nürnberg Medical School
Enrollment: 150
Locations: 1
Primary Endpoint: Change in Skeletal muscle mass
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

July 1, 2017

End Date

June 30, 2020

Last Updated

7 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

University of Erlangen-Nürnberg Medical School

Responsible Party

Sponsor

Eligibility Criteria

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
•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

Outcomes

Primary Outcomes

Change in Skeletal muscle mass

Time Frame: 12 weeks (palliative treatment), 3-4 weeks (curative treatment)

Skeletal muscle mass assessed by bioelectrical impedance analysis (in kg)

Period of hospitalization

Time Frame: 3-4 week (curative treatment)

Days of Hospital stay after curative surgery

Secondary Outcomes

Gastrointestinal toxicity of chemotherapy(12 weeks (palliative treatment), 3-4 weeks (curative treatment))
Physical function - Endurance(12 weeks (palliative treatment), 3-4 weeks (curative treatment))
Physical function - Isometric muscle strength(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))
Pain score(12 weeks (palliative treatment), 3-4 weeks (curative treatment))
Physical activity(12 weeks (palliative treatment), 3-4 weeks (curative treatment))
Patient-reported Fatigue(12 weeks (palliative treatment), 3-4 weeks (curative treatment))
Depression score(12 weeks (palliative treatment), 3-4 weeks (curative treatment))
Inflammatory status(12 weeks (palliative treatment), 3-4 weeks (curative treatment))