WB-EMS and Individualized Nutritional Support in Gynecological Cancer Patients

Not Applicable

• Conditions: Cachexia; Gynecologic Cancer

• 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

Study Timeline

• Study Start: 2017-07-01
• Status Verified: 2018-06
• Study First Submitted: 2018-06-01
• Study First Submitted QC: 2018-06-25
• Last Update Submitted: 2018-06-25
• Study First Posted: 2018-06-26
• Last Update Posted: 2018-06-26
• Primary Completion: 2020-06-30
• Study Completion: 2020-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

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