CancerNCT03151291
Effects of WB-EMS and Specific Dietary Supplements on Cancer Patients
A study testing β-hydroxy-β-methylbutyrate (HMB), L-carnitine (LC) and Eicosapentaenoic acid (EPA) in people with Cancer and Cancer Cachexia, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Cancer Cachexia, Weight Loss
- What is being tested?
- β-hydroxy-β-methylbutyrate (HMB), L-carnitine (LC) and Eicosapentaenoic acid (EPA)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteGermany
- Study dates
- Dec 2016to Apr 2019
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- energy active metals in body
- pregnancy
- acute vein thrombosis
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Hector-Center for Nutrition, Exercise and Sports
Erlangen, Bavaria, 91054
Yurdagül Zopf, Prof. Dr. med., +49 9131 85-45218, yurdaguel.zopf@k-erlangen.de
Hans Joachim Herrmann, Dr. oec. troph., +49 9131 85-45017, hans.herrmann@uk-erlangen.de
About this study
Official title: Effects of Physical Exercise in the Form of Whole-body Electromyostimulation (WB-EMS) Combined With Individualized Nutritional Therapy Using Specific Dietary Supplements on Cancer Patients Undergoing Curative or Palliative Anti-cancer Treatment
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.
- Conditions
- Cancer, Cancer Cachexia, Weight Loss, Muscle Loss, Muscle Weakness
- Being tested
- β-hydroxy-β-methylbutyrate (HMB), L-carnitine (LC), Eicosapentaenoic acid (EPA), Whole-Body Electromyostimulation (WB-EMS)
- Keywords
- cancer cachexia, WB-EMS, skeletal muscle mass, exercise, nutrition, dietary supplements
- Medical subject headings
- Neoplasms, Weight Loss, Muscular Atrophy, Muscle Weakness, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
β-hydroxy-β-methylbutyrate (HMB)Dietary supplement
daily intake of 3 g HMB
L-carnitine (LC)Dietary supplement
daily intake of 4 g LC
Eicosapentaenoic acid (EPA)Dietary supplement
daily intake of 2.2 g EPA
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 | No intervention | "usual care" control group receives individualized nutritional support (dietary advices: daily protein intake > 1.0 g/kg bodyweight) |
| EMS group | Experimental | 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) Receives: Other: Whole-Body Electromyostimulation (WB-EMS) |
| HMB group | Experimental | 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) Receives: Dietary Supplement: β-hydroxy-β-methylbutyrate (HMB) |
| HMB+EMS group | Experimental | 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) Receives: Dietary Supplement: β-hydroxy-β-methylbutyrate (HMB); Other: Whole-Body Electromyostimulation (WB-EMS) |
| LC group | Experimental | 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) Receives: Dietary Supplement: L-carnitine (LC) |
| LC+EMS group | Experimental | 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) Receives: Dietary Supplement: L-carnitine (LC); Other: Whole-Body Electromyostimulation (WB-EMS) |
| EPA group | Experimental | 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) Receives: Dietary Supplement: Eicosapentaenoic acid (EPA) |
| EPA+EMS group | Experimental | 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) Receives: Dietary Supplement: Eicosapentaenoic acid (EPA); Other: Whole-Body Electromyostimulation (WB-EMS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skeletal muscle mass
Skeletal muscle mass assessed by bioelectrical impedance analysis (in kg)
Measured: 12 weeks
Secondary outcomes (7)
Physical function - isometric muscle strength
Isometric hand grip strength assessed by hand Dynamometer (in kg)
Measured: 12 weeks
Physical function - Endurance
Six-minute-walk test (walking distance in m)
Measured: 12 weeks
Physical function - Lower limb strength
30 second sit-to-stand test (number of sit-to-stand cycles)
Measured: 12 weeks
Patient-reported performance status
ECOG performance status/Karnofsky index
Measured: 12 weeks
Patient-reported Quality of Life (QoL)
EORTC QLQ - C30 questionnaire
Measured: 12 weeks
Patient-reported Fatigue
FACIT-Fatigue scale
Measured: 12 weeks
Inflammatory blood markers
Blood collection and analysis of e.g. C-reactive protein (CRP), Albumin
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2017
- Study startDec 2016
- Primary completion31 Mar 2019 (estimated)
- Study completionApr 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 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
- NCT03151291
- Sponsor's protocol ID
- EMS and DS Tumor 01
- Status last verified
- Oct 2018
- First submitted
- 11 May 2017
- Last updated
- 16 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Physical Exercise in the Form of Whole-body Electromyostimulation (WB-EMS) Combined With Individualized Nutritional Therapy Using Specific Dietary Supplements on Cancer Patients Undergoing Curative or Palliative Anti-cancer Treatment
- ClinicalTrials.gov ID
- NCT03151291
- Acronym / sponsor ID
- EMS and DS Tumor 01
- Conditions
- Cancer, Cancer Cachexia, Weight Loss, Muscle Loss, Muscle Weakness
- Keywords
- cancer cachexia, WB-EMS, skeletal muscle mass, exercise, nutrition, dietary supplements
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of Erlangen-Nürnberg Medical SchoolUniversity, hospital or other
- Study start
- Dec 2016 (actual)
- Primary completion
- 31 Mar 2019 (estimated)
- Study completion
- Apr 2019 (estimated)
- First posted
- 12 May 2017 (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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –"usual care" control group receives individualized nutritional support (dietary advices: daily protein intake > 1.0 g/kg bodyweight) |
| EMS group | Experimental | Other: Whole-Body Electromyostimulation (WB-EMS)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) |
| HMB group | Experimental | Dietary Supplement: β-hydroxy-β-methylbutyrate (HMB)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) |
| HMB+EMS group | Experimental | Dietary Supplement: β-hydroxy-β-methylbutyrate (HMB), Other: Whole-Body Electromyostimulation (WB-EMS)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) |
| LC group | Experimental | Dietary Supplement: L-carnitine (LC)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) |
| LC+EMS group | Experimental | Dietary Supplement: L-carnitine (LC), Other: Whole-Body Electromyostimulation (WB-EMS)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) |
| EPA group | Experimental | Dietary Supplement: Eicosapentaenoic acid (EPA)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) |
| EPA+EMS group | Experimental | Dietary Supplement: Eicosapentaenoic acid (EPA), Other: Whole-Body Electromyostimulation (WB-EMS)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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (9 listed)
- simultaneous participation in other nutritional or exercise intervention trials
- 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 |
|---|---|---|
| β-hydroxy-β-methylbutyrate (HMB)daily intake of 3 g HMB | Dietary supplement | HMB group, HMB+EMS group |
| L-carnitine (LC)daily intake of 4 g LC | Dietary supplement | LC group, LC+EMS group |
| Eicosapentaenoic acid (EPA)daily intake of 2.2 g EPA | Dietary supplement | EPA group, EPA+EMS group |
| 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 | EMS group, EPA+EMS group, HMB+EMS group, LC+EMS group |
Primary outcome
Skeletal muscle mass
Time frame: 12 weeks
Skeletal muscle mass assessed by bioelectrical impedance analysis (in kg)
7 secondary outcomes
Physical function - isometric muscle strength
Time frame: 12 weeks
Physical function - Endurance
Time frame: 12 weeks
Physical function - Lower limb strength
Time frame: 12 weeks
Patient-reported performance status
Time frame: 12 weeks
Patient-reported Quality of Life (QoL)
Time frame: 12 weeks
Patient-reported Fatigue
Time frame: 12 weeks
Inflammatory blood markers
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2018.
- Individual participant dataSharing planned: No
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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 β-hydroxy-β-methylbutyrate (HMB), L-carnitine (LC) and Eicosapentaenoic acid (EPA) in people with Cancer and Cancer 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 2 inclusion and 9 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 16 Oct 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?
Skeletal muscle mass (time frame: 12 weeks). 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 16 Oct 2018.