CancerNCT03551990
Influence of Motor Proteins on Muscle Atrophy in Cancer Patients
A study testing whole-body electromyostimulation WB-EMS in people with Cancer and Muscle Atrophy, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.
Trial summary
The aim of the study is to investigate the effect of exercise in form of whole-body electromyostimulation (WB-EMS) on early tumor-induced muscular dysfunction. It is anticipated to gain detailed knowledge about composition and metabolism of skeletal muscle cells, and single muscle fiber functionality. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cancer, Muscle Atrophy
- What is being tested?
- whole-body electromyostimulation WB-EMS
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 420 participants
- Where
- 1 siteGermany
- Study dates
- 31 May 2017to Jun 2022
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients ≥ 18 years
- Solid pancreatic, colorectal, esophageal, gastric and liver tumors under oncological treatment
- Karnofsky performance index between 50 and 100
- Loss of body weight (≥ 2 % and < 5 %, weight before the illness and at study entry)
- Distinct decrease in muscle force
- Indication for surgery proximal to the M. rectus abdominis
- Intervention Group must have an at least 8-week waiting period until the surgery (to conduct WB-EMS)
Who cannot join
- Participation in other nutrition or exercise intervention studies
- Study-independent exercise more than once a week
- Ingestion of anabolic or dietary supplements
- Occurrence of heavy cardio-vascular events
- Epilepsy and other severe neurological disorders
- Skin lesions in the area of the electrodes
Show all 10Show fewer
- Conductive materials or electronical implants in the body (that do not allow electromyostimulation)
- Pregnancy
- Chronic diseases (e.g. HIV or Hepatitis C/D/E)
- Rejection of a muscle biopsy
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
The aim of the study is to investigate the effect of exercise in form of whole-body electromyostimulation (WB-EMS) on early tumor-induced muscular dysfunction. It is anticipated to gain detailed knowledge about composition and metabolism of skeletal muscle cells, and single muscle fiber functionality. To determine key factors leading to impaired force generation and thus decreased muscle strength in cancer patients who are suspected to develop or already show early signs of tumor cachexia is crucial for the establishment of effective cancer treatment. Comparative analysis of skeletal muscle biopsies taken from the abdomen of patients during indicated surgeries will be conducted. The patients will be allocated to the following study groups: a) Study group 1: Patients without cancer, b) Study group 2: Patients with solid tumors who did not perform physical training and c) Study group 3: Patients with solid tumors who executed physical training in form of WB-EMS. The investigation can help to understand skeletal muscle physiology under exercise and to get a better insight into the effects of physical training on early-stage muscle atrophy, both on cellular and molecular level. Initially, it is planned to identify the inflammation and nutrition status of the patients, and to determine skeletal muscle strength. It is anticipated to explore muscle protein composition, particularly myosin to actin ratio and their interaction. Biochemical analysis and the examination of the cellular ultra-structure should enhance the knowledge about the key mechanisms controlling the contractile apparatus of single muscle fibers in order to determine the quality of muscle force. Taken together, these investigations will help to better understand muscle atrophy in advanced cancer patients, and might support the development of targeted anti-cachectic therapies, that can be applied already in early phases of the tumor disease to significantly improve the patients' prognosis and their quality of life.
- Conditions
- Cancer, Muscle Atrophy
- Being tested
- whole-body electromyostimulation WB-EMS
- Keywords
- Whole-body electromyostimulation, WB-EMS, Cancer, Muscle atrophy, Muscle protein, Exercise, Muscle fiber
- Medical subject headings
- Neoplasms, Muscular Atrophy, 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-EMSProcedure or surgery
Patients of the WB-EMS group will perform whole-body electromyostimulation (WB-EMS) training sessions twice a week over a period of 8 weeks. To allow muscle recovery a break of at least 2 days between the sessions will be scheduled. To adapt the patients to the WB-EMS intervention, the training duration will be gradually increased (week 1, 12 min; increase of 2 min/week; week 5-8, 20 min). WB-EMS training sessions will include light physical exercises according to a video tutorial and individually supervised by certified physio therapists.
| Study group | Role | What they receive |
|---|---|---|
| Control group; patients without a tumor disease, surgery | No intervention | Control group with patients without a tumor disease but with indication for surgery in close proximity to the M. rectus abdominis |
| Control group; tumor patients, surgery | No intervention | Control group with patients with solid tumors; patients with pancreatic, colorectal, esophageal, gastric and liver solid tumors with indication for surgery in close proximity to the M. rectus abdominis |
| Intervention group; tumor patients, WB-EMS, surgery | Experimental | Intervention group with patients with solid tumors who do perform an 8-week physical training in form of whole-body electromyostimulation (WB-EMS); patients with pancreatic, colorectal, esophageal, gastric and liver solid tumors with indication for surgery in close proximity to the M. rectus abdominis Receives: Procedure: whole-body electromyostimulation WB-EMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences in Myosin:Actin ratio
Myosin:Actin ratio in the muscle biopsies assessed by protein analysis via Western Blotting.
Measured: 8 weeks
Differences in Myosin isoforms
The Myosin isoforms in the muscle biopsies will be determined by protein expression analysis via Western Blotting.
Measured: 8 weeks
Differences in cellular ultra structures
Cellular ultra structures in the muscle biopsies will be examined using multi-photon microscopy.
Measured: 8 weeks
Differences in Force development and Calcium 2+ sensitivity of single muscle fibers
Force development and Calcium 2+ sensitivity of single muscle fibers from the muscle biopsies will be assessed by in situ biomechanical recording.
Measured: 8 weeks
Differences in activation of involved signaling pathways
Signaling pathways that regulate muscle atrophy will be analyzed by examining protein expression and modification (Western Blotting), and gene expression (quantitative PCR) in the muscle biopsies.
Measured: 8 weeks
Secondary outcomes (2)
Differences in inflammatory status
Pro-inflammatory cytokines
Measured: 0 week
Differences in Nutritional risk
Nutritional Risk Screening-2002
Measured: 0 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2018
- Study start31 May 2017
- Primary completionDec 2021 (estimated)
- Study completionJun 2022 (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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 420 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
- NCT03551990
- Sponsor's protocol ID
- EMS Tumor Motor Proteins
- Status last verified
- May 2018
- First submitted
- 10 May 2017
- Last updated
- 11 Jun 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 11 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Motor Proteins on Muscle Atrophy in Cancer Patients
- ClinicalTrials.gov ID
- NCT03551990
- Acronym / sponsor ID
- EMS Tumor Motor Proteins
- Conditions
- Cancer, Muscle Atrophy
- Keywords
- Whole-body electromyostimulation, WB-EMS, Cancer, Muscle atrophy, Muscle protein, Exercise, Muscle fiber
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 420 participants (estimated)
- Lead sponsor
- University of Erlangen-Nürnberg Medical SchoolUniversity, hospital or other
- Study start
- 31 May 2017 (actual)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Jun 2022 (estimated)
- First posted
- 11 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.
The aim of the study is to investigate the effect of exercise in form of whole-body electromyostimulation (WB-EMS) on early tumor-induced muscular dysfunction. It is anticipated to gain detailed knowledge about composition and metabolism of skeletal muscle cells, and single muscle fiber functionality. To determine key factors leading to impaired force generation and thus decreased muscle strength in cancer patients who are suspected to develop or already show early signs of tumor cachexia is crucial for the establishment of effective cancer treatment. Comparative analysis of skeletal muscle biopsies taken from the abdomen of patients during indicated surgeries will be conducted. The patients will be allocated to the following study groups: a) Study group 1: Patients without cancer, b) Study group 2: Patients with solid tumors who did not perform physical training and c) Study group 3: Patients with solid tumors who executed physical training in form of WB-EMS. The investigation can help to understand skeletal muscle physiology under exercise and to get a better insight into the effects of physical training on early-stage muscle atrophy, both on cellular and molecular level. Initially, it is planned to identify the inflammation and nutrition status of the patients, and to determine skeletal muscle strength. It is anticipated to explore muscle protein composition, particularly myosin to actin ratio and their interaction. Biochemical analysis and the examination of the cellular ultra-structure should enhance the knowledge about the key mechanisms controlling the contractile apparatus of single muscle fibers in order to determine the quality of muscle force. Taken together, these investigations will help to better understand muscle atrophy in advanced cancer patients, and might support the development of targeted anti-cachectic therapies, that can be applied already in early phases of the tumor disease to significantly improve the patients' prognosis and their quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group; patients without a tumor disease, surgery | No intervention | –Control group with patients without a tumor disease but with indication for surgery in close proximity to the M. rectus abdominis |
| Control group; tumor patients, surgery | No intervention | –Control group with patients with solid tumors; patients with pancreatic, colorectal, esophageal, gastric and liver solid tumors with indication for surgery in close proximity to the M. rectus abdominis |
| Intervention group; tumor patients, WB-EMS, surgery | Experimental | Procedure: whole-body electromyostimulation WB-EMSIntervention group with patients with solid tumors who do perform an 8-week physical training in form of whole-body electromyostimulation (WB-EMS); patients with pancreatic, colorectal, esophageal, gastric and liver solid tumors with indication for surgery in close proximity to the M. rectus abdominis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients ≥ 18 years
- Solid pancreatic, colorectal, esophageal, gastric and liver tumors under oncological treatment
- Karnofsky performance index between 50 and 100
- Loss of body weight (≥ 2 % and < 5 %, weight before the illness and at study entry)
- Distinct decrease in muscle force
Key exclusion criteria (10 listed)
- Participation in other nutrition or exercise intervention studies
- Study-independent exercise more than once a week
- Ingestion of anabolic or dietary supplements
- Occurrence of heavy cardio-vascular events
- Epilepsy and other severe neurological disorders
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-EMSPatients of the WB-EMS group will perform whole-body electromyostimulation (WB-EMS) training sessions twice a week over a period of 8 weeks. To allow muscle recovery a break of at least 2 days between the sessions will be scheduled. To adapt the patients to the WB-EMS intervention, the training duration will be gradually increased (week 1, 12 min; increase of 2 min/week; week 5-8, 20 min). WB-EMS training sessions will include light physical exercises according to a video tutorial and individually supervised by certified physio therapists. | Procedure or surgery | Intervention group; tumor patients, WB-EMS, surgery |
Primary outcome
Differences in Myosin:Actin ratio
Time frame: 8 weeks
Myosin:Actin ratio in the muscle biopsies assessed by protein analysis via Western Blotting.
Differences in Myosin isoforms
Time frame: 8 weeks
The Myosin isoforms in the muscle biopsies will be determined by protein expression analysis via Western Blotting.
Differences in cellular ultra structures
Time frame: 8 weeks
Cellular ultra structures in the muscle biopsies will be examined using multi-photon microscopy.
Differences in Force development and Calcium 2+ sensitivity of single muscle fibers
Time frame: 8 weeks
Force development and Calcium 2+ sensitivity of single muscle fibers from the muscle biopsies will be assessed by in situ biomechanical recording.
Differences in activation of involved signaling pathways
Time frame: 8 weeks
Signaling pathways that regulate muscle atrophy will be analyzed by examining protein expression and modification (Western Blotting), and gene expression (quantitative PCR) in the muscle biopsies.
2 secondary outcomes
Differences in inflammatory status
Time frame: 0 week
Differences in Nutritional risk
Time frame: 0 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 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.
Hector-Center for Nutrition, Exercise and Sports
Erlangen, Germany
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 Cancer and Muscle Atrophy, 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 7 inclusion and 10 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 11 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differences in Myosin:Actin ratio (time frame: 8 weeks). The study lists 5 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 11 Jun 2018.