WB-EMS and Individualized Nutritional Support in Gynecological Cancer Patients

Gynecologic Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03570242
• Other study ID #: Gyn EMS
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2017
• Est. completion date: June 30, 2020

Study information

• Verified date: June 2018
• Source: University of Erlangen-Nürnberg Medical School
• Contact: Yurdagül Zopf, Prof. Dr. med.
• Phone: +49 9131 85-45218
• Email: yurdaguel.zopf[@]uk-erlangen.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: June 30, 2020
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cachexia
• Gynecologic Cancer

Intervention

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

Locations

Country	Name	City	State
Germany	Department of Medicine 1, Hector Center for Nutrition, Exercise and Sports, Friedrich-Alexander-University Erlangen-Nuremberg	Erlangen

Sponsors (1)

Lead Sponsor	Collaborator
University of Erlangen-Nürnberg Medical School

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Skeletal muscle mass	Skeletal muscle mass assessed by bioelectrical impedance analysis (in kg)	12 weeks (palliative treatment), 3-4 weeks (curative treatment)
Primary	Period of hospitalization	Days of Hospital stay after curative surgery	3-4 week (curative treatment)
Secondary	Physical function - Isometric muscle strength	Hand grip strength assessed by hand dynamometer (in kg)	12 weeks (palliative treatment), 3-4 weeks (curative treatment)
Secondary	Physical function - Endurance	Six-minute-walk test (walking distance in m)	12 weeks (palliative treatment), 3-4 weeks (curative treatment)
Secondary	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)
Secondary	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
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	Physical activity	International Physical Activity Questionnaire (IPAQ); Higher score indicates higher physical acitivity level	12 weeks (palliative treatment), 3-4 weeks (curative treatment)
Secondary	Inflammatory status	Analysis of serum C-reactive protein (CRP) and albumin concentrations	12 weeks (palliative treatment), 3-4 weeks (curative treatment)