Effects of WB-EMS and Specific Dietary Supplements on Cancer Patients

NCT ID: NCT03151291

Last Updated: 2018-10-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-31

Study Completion Date

2019-04-30

Brief Summary

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Patients suffering from cancer often experience a loss of muscle mass and strength during disease and its therapy. Muscle wasting is the main characteristic of the so-called cancer cachexia syndrome and responsible for many therapy-related complications and a poorer prognosis of the patient. Stabilizing muscle mass should therefore be a great goal in cancer care. Physical exercise and nutrition are promising measures to combat cancer-related muscle atrophy but conventional exercise programs may not always be suitable for physical-weakened patients and increased catabolic processes are difficult to overcome by normal Nutrition - especially in advanced cancer. Therefore, the present study aims to test a combined approach of specific nutritional supplementation and exercise using the novel strength training method of Whole-Body electromyostimulation (WB-EMS). The study investigates the effect of a 12-week WB-EMS training combined with a dietary supplementation of β-hydroxy-β-methylbutyrate (HMB), L-carnitine (LC) or the omega-3-fatty acid eicosapentaenoic acid (EPA) on skeletal muscle mass, body composition, physical function, nutritional and inflammatory status, fatigue and quality of life in cancer patients undergoing oncological treatment. The results of this study may help to clarify the effectiveness of those combined interventions to counteract muscle wasting and other symptoms of cancer cachexia.

Detailed Description

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Conditions

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Cancer Cancer Cachexia Weight Loss Muscle Loss Muscle Weakness

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

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Control group

"usual care" control group receives individualized nutritional support (dietary advices: daily protein intake \> 1.0 g/kg bodyweight)

Group Type NO_INTERVENTION

No interventions assigned to this group

EMS group

physical exercise group performing a regular WB-EMS Training (two WB-EMS trainings per week; each session for 20 min)

\+ individualized nutritional support (dietary advices: daily protein intake \> 1.0 g/kg bodyweight)

Group Type EXPERIMENTAL

Whole-Body Electromyostimulation (WB-EMS)

Intervention Type 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

HMB group

HMB supplemented group receives individualized nutritional support (dietary advices: daily protein intake \> 1.0 g/kg bodyweight) + specific dietary supplementation with HMB (3 g/d)

Group Type EXPERIMENTAL

β-hydroxy-β-methylbutyrate (HMB)

Intervention Type DIETARY_SUPPLEMENT

daily intake of 3 g HMB

HMB+EMS group

HMB supplemented physical exercise group performing a regular WB-EMS Training (two WB-EMS trainings per week; each session for 20 min)

\+ individualized nutritional support (dietary advices: daily protein intake \> 1.0 g/kg bodyweight) + specific dietary supplementation with HMB (3 g/d)

Group Type EXPERIMENTAL

β-hydroxy-β-methylbutyrate (HMB)

Intervention Type DIETARY_SUPPLEMENT

daily intake of 3 g HMB

Whole-Body Electromyostimulation (WB-EMS)

Intervention Type 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

LC group

LC supplemented group receives individualized nutritional support (dietary advices: daily protein intake \> 1.0 g/kg bodyweight) + specific dietary supplementation with LC (4 g/d)

Group Type EXPERIMENTAL

L-carnitine (LC)

Intervention Type DIETARY_SUPPLEMENT

daily intake of 4 g LC

LC+EMS group

LC supplemented physical exercise group performing a regular WB-EMS Training (two WB-EMS trainings per week; each session for 20 min)

\+ individualized nutritional support (dietary advices: daily protein intake \> 1.0 g/kg bodyweight) + specific dietary supplementation with LC (4 g/d)

Group Type EXPERIMENTAL

L-carnitine (LC)

Intervention Type DIETARY_SUPPLEMENT

daily intake of 4 g LC

Whole-Body Electromyostimulation (WB-EMS)

Intervention Type 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

EPA group

EPA supplemented group receives individualized nutritional support (dietary advices: daily protein intake \> 1.0 g/kg bodyweight) + specific dietary supplementation with EPA (2.2 g/d)

Group Type EXPERIMENTAL

Eicosapentaenoic acid (EPA)

Intervention Type DIETARY_SUPPLEMENT

daily intake of 2.2 g EPA

EPA+EMS group

EPA supplemented physical exercise group performing a regular WB-EMS Training (two WB-EMS trainings per week; each session for 20 min)

\+ individualized nutritional support (dietary advices: daily protein intake \> 1.0 g/kg bodyweight) + specific dietary supplementation with EPA (2.2 g/d)

Group Type EXPERIMENTAL

Eicosapentaenoic acid (EPA)

Intervention Type DIETARY_SUPPLEMENT

daily intake of 2.2 g EPA

Whole-Body Electromyostimulation (WB-EMS)

Intervention Type 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

Interventions

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β-hydroxy-β-methylbutyrate (HMB)

daily intake of 3 g HMB

Intervention Type DIETARY_SUPPLEMENT

L-carnitine (LC)

daily intake of 4 g LC

Intervention Type DIETARY_SUPPLEMENT

Eicosapentaenoic acid (EPA)

daily intake of 2.2 g EPA

Intervention Type DIETARY_SUPPLEMENT

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* malignant disease (solid or hematological cancer) e.g. head and neck cancer, colorectal carcinoma, small intestinal cancer, gastric cancer, oesophageal cancer, pancreas carcinoma, liver cell carcinoma, cholangiocarcinoma,lung cancer, breast cancer, cervix cancer, ovarian cancer, prostate cancer, renal cell carcinoma, malignant melanoma, patients with leukaemia and malignant lymphomas
* ECOG Performance Status ≤ 2

Exclusion Criteria

* simultaneous participation in other nutritional or exercise intervention trials
* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Erlangen-Nürnberg Medical School

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hector-Center for Nutrition, Exercise and Sports

Erlangen, Bavaria, Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Yurdagül Zopf, Prof. Dr. med.

Role: CONTACT

+49 9131 85-45218

Hans Joachim Herrmann, Dr. oec. troph.

Role: CONTACT

+49 9131 85-45017

Facility Contacts

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Yurdagül Zopf, Prof. Dr. med.

Role: primary

+49 9131 85-45218

Hans Joachim Herrmann, Dr. oec. troph.

Role: backup

+49 9131 85-45017

Other Identifiers

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EMS and DS Tumor 01

Identifier Type: -

Identifier Source: org_study_id

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