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WB-EMS and Individualized Nutritional Support in Gynecological Cancer Patients

Primary Purpose

Gynecologic Cancer, Cachexia

Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Whole-Body Electromyostimulation (WB-EMS)
Sponsored by
University of Erlangen-Nürnberg Medical School
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Gynecologic Cancer focused on measuring gynecologic cancer, WB-EMS, whole-body electromyostimulation, nutrition, protein, exercise, cancer cachexia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

  • Department of Medicine 1, Hector Center for Nutrition, Exercise and Sports, Friedrich-Alexander-University Erlangen-NurembergRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

No Intervention

Experimental

No Intervention

Experimental

Arm Label

Control group (palliative treatment)

WB-EMS group (palliative treatment)

Control group (curative treatment)

WB-EMS group (curative treatment)

Arm Description

"usual care" control group (includes patients undergoing palliative Treatment) receives individualized nutritional support (dietary advices: daily protein intake1,2 - 1,5 g/kg bodyweight)

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)

"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)

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)

Outcomes

Primary Outcome Measures

Change in Skeletal muscle mass
Skeletal muscle mass assessed by bioelectrical impedance analysis (in kg)
Period of hospitalization
Days of Hospital stay after curative surgery

Secondary Outcome Measures

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

Full Information

First Posted
June 1, 2018
Last Updated
June 25, 2018
Sponsor
University of Erlangen-Nürnberg Medical School
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1. Study Identification

Unique Protocol Identification Number
NCT03570242
Brief Title
WB-EMS and Individualized Nutritional Support in Gynecological Cancer Patients
Official Title
Effect of Whole-body Electromyostimulation Combined With Individualized Nutritional Support on Patients With Gynecological Cancer Undergoing Curative and Palliative Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2017 (Actual)
Primary Completion Date
June 30, 2020 (Anticipated)
Study Completion Date
June 30, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Erlangen-Nürnberg Medical School

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gynecologic Cancer, Cachexia
Keywords
gynecologic cancer, WB-EMS, whole-body electromyostimulation, nutrition, protein, exercise, cancer cachexia

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control group (palliative treatment)
Arm Type
No Intervention
Arm Description
"usual care" control group (includes patients undergoing palliative Treatment) receives individualized nutritional support (dietary advices: daily protein intake1,2 - 1,5 g/kg bodyweight)
Arm Title
WB-EMS group (palliative treatment)
Arm Type
Experimental
Arm Description
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)
Arm Title
Control group (curative treatment)
Arm Type
No Intervention
Arm Description
"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)
Arm Title
WB-EMS group (curative treatment)
Arm Type
Experimental
Arm Description
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)
Intervention Type
Other
Intervention Name(s)
Whole-Body Electromyostimulation (WB-EMS)
Intervention Description
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
Primary Outcome Measure Information:
Title
Change in Skeletal muscle mass
Description
Skeletal muscle mass assessed by bioelectrical impedance analysis (in kg)
Time Frame
12 weeks (palliative treatment), 3-4 weeks (curative treatment)
Title
Period of hospitalization
Description
Days of Hospital stay after curative surgery
Time Frame
3-4 week (curative treatment)
Secondary Outcome Measure Information:
Title
Physical function - Isometric muscle strength
Description
Hand grip strength assessed by hand dynamometer (in kg)
Time Frame
12 weeks (palliative treatment), 3-4 weeks (curative treatment)
Title
Physical function - Endurance
Description
Six-minute-walk test (walking distance in m)
Time Frame
12 weeks (palliative treatment), 3-4 weeks (curative treatment)
Title
Physical function - Lower limb strength
Description
30 second sit-to-stand test (number of sit-to-stand cycles)
Time Frame
12 weeks (palliative treatment), 3-4 weeks (curative treatment)
Title
Patient-reported performance status
Description
Karnofsky index
Time Frame
12 weeks (palliative treatment), 3-4 weeks (curative treatment), Total Score ranges from 0-100 with a higher score indicating better performance status
Title
Patient-reported Quality of Life (QoL)
Description
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
Time Frame
12 weeks (palliative treatment), 3-4 weeks (curative treatment)
Title
Patient-reported Fatigue
Description
FACIT-Fatigue scale; Total score ranges from 0-52 with a higher score indicating better Quality of life/less fatigue
Time Frame
12 weeks (palliative treatment), 3-4 weeks (curative treatment)
Title
Pain score
Description
Visual Analogue Scale (VAS); Total score ranges from 0-10 with a higher score indicating higher pain
Time Frame
12 weeks (palliative treatment), 3-4 weeks (curative treatment)
Title
Depression score
Description
Beck Depression Inventory (BDI); Total score ranges from 0-63 with higher score indicating higher depression
Time Frame
12 weeks (palliative treatment), 3-4 weeks (curative treatment)
Title
Gastrointestinal toxicity of chemotherapy
Description
Number of participants with treatment-related adverse events of gastrointestinal toxicity as assessed by CTCAE v4.0
Time Frame
12 weeks (palliative treatment), 3-4 weeks (curative treatment)
Title
Physical activity
Description
International Physical Activity Questionnaire (IPAQ); Higher score indicates higher physical acitivity level
Time Frame
12 weeks (palliative treatment), 3-4 weeks (curative treatment)
Title
Inflammatory status
Description
Analysis of serum C-reactive protein (CRP) and albumin concentrations
Time Frame
12 weeks (palliative treatment), 3-4 weeks (curative treatment)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yurdagül Zopf, Prof. Dr. med.
Phone
+49 9131 85-45218
Email
yurdaguel.zopf@uk-erlangen.de
First Name & Middle Initial & Last Name or Official Title & Degree
Hans Joachim Herrmann, Dr. oec. troph.
Phone
+49 9131 85-45017
Email
hans.herrmann@uk-erlangen.de
Facility Information:
Facility Name
Department of Medicine 1, Hector Center for Nutrition, Exercise and Sports, Friedrich-Alexander-University Erlangen-Nuremberg
City
Erlangen
ZIP/Postal Code
91052
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yurdaguel Zopf, Prof. Dr. med.
Email
yurdaguel.zopf@uk-erlangen.de

12. IPD Sharing Statement

Learn more about this trial

WB-EMS and Individualized Nutritional Support in Gynecological Cancer Patients

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