WB-EMS and Individualized Nutritional Support in Gynecological Cancer Patients

Sponsor

University of Erlangen-Nürnberg Medical School (Other)

Overall Status

Unknown status

CT.gov ID

NCT03570242

Collaborator

(none)

150

Enrollment

Location

Arms

Anticipated Duration (Months)

4.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Gynecologic Cancer Cachexia	Other: Whole-Body Electromyostimulation (WB-EMS)	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

150 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Jul 1, 2017

Anticipated Primary Completion Date :

Jun 30, 2020

Anticipated Study Completion Date :

Jun 30, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

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

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 - Endurance [12 weeks (palliative treatment), 3-4 weeks (curative treatment)]
Six-minute-walk test (walking distance in m)
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
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
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
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
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 activity [12 weeks (palliative treatment), 3-4 weeks (curative treatment)]
International Physical Activity Questionnaire (IPAQ); Higher score indicates higher physical acitivity level
Inflammatory status [12 weeks (palliative treatment), 3-4 weeks (curative treatment)]
Analysis of serum C-reactive protein (CRP) and albumin concentrations

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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