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

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.

Study Overview

• Status: Unknown
• Conditions: Gynecologic Cancer; Cachexia
• Intervention / Treatment: Other: Whole-Body Electromyostimulation (WB-EMS)

• Study Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Erlangen, Germany, 91052
    • Recruiting
    • Department of Medicine 1, Hector Center for Nutrition, Exercise and Sports, Friedrich-Alexander-University Erlangen-Nuremberg
    • Contact: Yurdaguel Zopf, Prof. Dr. med.; Email: yurdaguel.zopf@uk-erlangen.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group (palliative treatment); "usual care" control group (includes patients undergoing palliative Treatment) receives individualized nutritional support (dietary advices: daily protein intake1,2 - 1,5 g/kg bodyweight)
Experimental: WB-EMS group (palliative treatment); 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)	Other: Whole-Body Electromyostimulation (WB-EMS); 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
No Intervention: Control group (curative treatment); "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)
Experimental: WB-EMS group (curative treatment); 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)	Other: Whole-Body Electromyostimulation (WB-EMS); 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physical function - Isometric muscle strength	Hand grip strength assessed by hand dynamometer (in kg)	12 weeks (palliative treatment), 3-4 weeks (curative treatment)
Physical function - Endurance	Six-minute-walk test (walking distance in m)	12 weeks (palliative treatment), 3-4 weeks (curative treatment)
Physical function - Lower limb strength	30 second sit-to-stand test (number of sit-to-stand cycles)	12 weeks (palliative treatment), 3-4 weeks (curative treatment)
Patient-reported performance status	Karnofsky index	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)	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	12 weeks (palliative treatment), 3-4 weeks (curative treatment)
Patient-reported Fatigue	FACIT-Fatigue scale; Total score ranges from 0-52 with a higher score indicating better Quality of life/less fatigue	12 weeks (palliative treatment), 3-4 weeks (curative treatment)
Pain score	Visual Analogue Scale (VAS); Total score ranges from 0-10 with a higher score indicating higher pain	12 weeks (palliative treatment), 3-4 weeks (curative treatment)
Depression score	Beck Depression Inventory (BDI); Total score ranges from 0-63 with higher score indicating higher depression	12 weeks (palliative treatment), 3-4 weeks (curative treatment)
Gastrointestinal toxicity of chemotherapy	Number of participants with treatment-related adverse events of gastrointestinal toxicity as assessed by CTCAE v4.0	12 weeks (palliative treatment), 3-4 weeks (curative treatment)
Physical activity	International Physical Activity Questionnaire (IPAQ); Higher score indicates higher physical acitivity level	12 weeks (palliative treatment), 3-4 weeks (curative treatment)
Inflammatory status	Analysis of serum C-reactive protein (CRP) and albumin concentrations	12 weeks (palliative treatment), 3-4 weeks (curative treatment)

Collaborators and Investigators

• Sponsor: University of Erlangen-Nürnberg Medical School

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2017
• Primary Completion (Anticipated): June 30, 2020
• Study Completion (Anticipated): June 30, 2020

Study Registration Dates

• First Submitted: June 1, 2018
• First Submitted That Met QC Criteria: June 25, 2018
• First Posted (Actual): June 26, 2018

Study Record Updates

• Last Update Posted (Actual): June 26, 2018
• Last Update Submitted That Met QC Criteria: June 25, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Keywords: exercise; nutrition; whole-body electromyostimulation; gynecologic cancer; protein; cancer cachexia; WB-EMS
• Additional Relevant MeSH Terms: Metabolic Diseases; Nutrition Disorders; Body Weight; Body Weight Changes; Emaciation; Weight Loss; Wasting Syndrome; Cachexia
• Other Study ID Numbers: Gyn EMS

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No