An interventional study of whole-body electromyostimulation WB-EMS in Cancer and Muscle Atrophy, sponsored by University of Erlangen-Nürnberg Medical School. Status unknown at 1 site in Germany. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-06-11.
Sponsored by University of Erlangen-Nürnberg Medical School · Not applicable, Interventional, and Treatment
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.
9,610 studies on the registry are indexed under Neoplasms; 2,508 are open to participants now.
This study's planned enrollment of 420 is above the median of 50 across 7,429 interventional studies indexed under Neoplasms.
Browse Neoplasms studies →University of Erlangen-Nürnberg Medical School is the lead sponsor of 275 studies on the registry; 52 are open to participants now.
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Exclusion Criteria:
Control group with patients without a tumor disease but with indication for surgery in close proximity to the M. rectus abdominis
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 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
Procedure: whole-body electromyostimulation WB-EMS
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.
Differences in Myosin:Actin ratio
Myosin:Actin ratio in the muscle biopsies assessed by protein analysis via Western Blotting.
Time frame: 8 weeks
Differences in Myosin isoforms
The Myosin isoforms in the muscle biopsies will be determined by protein expression analysis via Western Blotting.
Time frame: 8 weeks
Differences in cellular ultra structures
Cellular ultra structures in the muscle biopsies will be examined using multi-photon microscopy.
Time frame: 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.
Time frame: 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.
Time frame: 8 weeks
Differences in inflammatory status
Pro-inflammatory cytokines
Time frame: 0 week
Differences in Nutritional risk
Nutritional Risk Screening-2002
Time frame: 0 week
Plan to share: No
No publications or documents are linked to this record.
Started May 2017 (actual). Primary completion is estimated for Dec 2021, 55 months after the start.
Of 1,358 non-industry interventional studies with no phase under Neoplasms, half reached primary completion within 37 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 71. This study's planned 55 months is above that.
Counting every sponsor, half of 1,404 studies reached it within 38 months; a quarter within 17 and three quarters within 71.
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This study is status unknown, as verified in May 2018. You cannot join it, but the record below documents what was studied.
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University of Erlangen-Nürnberg Medical School →