Gynecologic CancerNCT03570242
WB-EMS and Individualized Nutritional Support in Gynecological Cancer Patients
A study testing Whole-Body Electromyostimulation (WB-EMS) in people with Gynecologic Cancer and Cachexia, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.
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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Gynecologic Cancer, Cachexia
- What is being tested?
- Whole-Body Electromyostimulation (WB-EMS)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jul 2017to 30 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- female patients with gynecological cancer undergoing palliative or curative treatment
- 18 years and older
- ECOG status > 2
Who cannot join
- 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
Show all 12Show fewer
- energy active metals in body
- pregnancy
- acute vein thrombosis
- rheumatic diseases
- pregnant and nursing women
- psychiatric disorders with doubts about legal and cognitive capacity
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Department of Medicine 1, Hector Center for Nutrition, Exercise and Sports, Friedrich-Alexander-University Erlangen-Nuremberg
Erlangen, 91052
Yurdaguel Zopf, Prof. Dr. med., yurdaguel.zopf@uk-erlangen.de
About this study
Official title: 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.
- Conditions
- Gynecologic Cancer, Cachexia
- Being tested
- Whole-Body Electromyostimulation (WB-EMS)
- Keywords
- gynecologic cancer, WB-EMS, whole-body electromyostimulation, nutrition, protein, exercise, cancer cachexia
- Medical subject headings
- Cachexia, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whole-Body Electromyostimulation (WB-EMS)Other
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
| Study group | Role | What they receive |
|---|---|---|
| Control group (palliative treatment) | No intervention | "usual care" control group (includes patients undergoing palliative Treatment) receives individualized nutritional support (dietary advices: daily protein intake1,2 - 1,5 g/kg bodyweight) |
| WB-EMS group (palliative treatment) | Experimental | 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) Receives: Other: Whole-Body Electromyostimulation (WB-EMS) |
| Control group (curative treatment) | No intervention | "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) |
| WB-EMS group (curative treatment) | Experimental | 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) Receives: Other: Whole-Body Electromyostimulation (WB-EMS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Skeletal muscle mass
Skeletal muscle mass assessed by bioelectrical impedance analysis (in kg)
Measured: 12 weeks (palliative treatment), 3-4 weeks (curative treatment)
Period of hospitalization
Days of Hospital stay after curative surgery
Measured: 3-4 week (curative treatment)
Secondary outcomes (11)
Physical function - Isometric muscle strength
Hand grip strength assessed by hand dynamometer (in kg)
Measured: 12 weeks (palliative treatment), 3-4 weeks (curative treatment)
Physical function - Endurance
Six-minute-walk test (walking distance in m)
Measured: 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)
Measured: 12 weeks (palliative treatment), 3-4 weeks (curative treatment)
Patient-reported performance status
Karnofsky index
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 12 weeks (palliative treatment), 3-4 weeks (curative treatment)
Physical activity
International Physical Activity Questionnaire (IPAQ); Higher score indicates higher physical acitivity level
Measured: 12 weeks (palliative treatment), 3-4 weeks (curative treatment)
Inflammatory status
Analysis of serum C-reactive protein (CRP) and albumin concentrations
Measured: 12 weeks (palliative treatment), 3-4 weeks (curative treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2018
- Study start1 Jul 2017
- Primary completion30 Jun 2020 (estimated)
- Study completion30 Jun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gynecologic CancerStudies of the same condition, open and under way.
- More trials run by University of Erlangen-Nürnberg Medical SchoolThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Erlangen-Nürnberg Medical School
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03570242
- Sponsor's protocol ID
- Gyn EMS
- Status last verified
- Jun 2018
- First submitted
- 1 Jun 2018
- Last updated
- 26 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Whole-body Electromyostimulation Combined With Individualized Nutritional Support on Patients With Gynecological Cancer Undergoing Curative and Palliative Treatment
- ClinicalTrials.gov ID
- NCT03570242
- Acronym / sponsor ID
- Gyn EMS
- Conditions
- Gynecologic Cancer, Cachexia
- Keywords
- gynecologic cancer, WB-EMS, whole-body electromyostimulation, nutrition, protein, exercise, cancer cachexia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University of Erlangen-Nürnberg Medical SchoolUniversity, hospital or other
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 30 Jun 2020 (estimated)
- Study completion
- 30 Jun 2020 (estimated)
- First posted
- 26 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control group (palliative treatment) | No intervention | –"usual care" control group (includes patients undergoing palliative Treatment) receives individualized nutritional support (dietary advices: daily protein intake1,2 - 1,5 g/kg bodyweight) |
| WB-EMS group (palliative treatment) | Experimental | Other: Whole-Body Electromyostimulation (WB-EMS)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) |
| Control group (curative treatment) | No intervention | –"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) |
| WB-EMS group (curative treatment) | Experimental | Other: Whole-Body Electromyostimulation (WB-EMS)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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- female patients with gynecological cancer undergoing palliative or curative treatment
- 18 years and older
- ECOG status > 2
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Other | WB-EMS group (curative treatment), WB-EMS group (palliative treatment) |
Primary outcome
Change in Skeletal muscle mass
Time frame: 12 weeks (palliative treatment), 3-4 weeks (curative treatment)
Skeletal muscle mass assessed by bioelectrical impedance analysis (in kg)
Period of hospitalization
Time frame: 3-4 week (curative treatment)
Days of Hospital stay after curative surgery
11 secondary outcomes
Physical function - Isometric muscle strength
Time frame: 12 weeks (palliative treatment), 3-4 weeks (curative treatment)
Physical function - Endurance
Time frame: 12 weeks (palliative treatment), 3-4 weeks (curative treatment)
Physical function - Lower limb strength
Time frame: 12 weeks (palliative treatment), 3-4 weeks (curative treatment)
Patient-reported performance status
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
Patient-reported Quality of Life (QoL)
Time frame: 12 weeks (palliative treatment), 3-4 weeks (curative treatment)
Patient-reported Fatigue
Time frame: 12 weeks (palliative treatment), 3-4 weeks (curative treatment)
Pain score
Time frame: 12 weeks (palliative treatment), 3-4 weeks (curative treatment)
Depression score
Time frame: 12 weeks (palliative treatment), 3-4 weeks (curative treatment)
Gastrointestinal toxicity of chemotherapy
Time frame: 12 weeks (palliative treatment), 3-4 weeks (curative treatment)
Physical activity
Time frame: 12 weeks (palliative treatment), 3-4 weeks (curative treatment)
Inflammatory status
Time frame: 12 weeks (palliative treatment), 3-4 weeks (curative treatment)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Whole-Body Electromyostimulation (WB-EMS) in people with Gynecologic Cancer and Cachexia, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yurdagül Zopf, Prof. Dr. med. (+49 9131 85-45218, yurdaguel.zopf@uk-erlangen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Skeletal muscle mass (time frame: 12 weeks (palliative treatment), 3-4 weeks (curative treatment)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2018.