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Influence of Motor Proteins on Muscle Atrophy in Cancer Patients

Influence of Motor Proteins on Muscle Atrophy in Cancer Patients

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03551990
Enrollment
420
Registered
2018-06-11
Start date
2017-05-31
Completion date
2022-06-30
Last updated
2018-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer, Muscle Atrophy

Keywords

Whole-body electromyostimulation, WB-EMS, Cancer, Muscle atrophy, Muscle protein, Exercise, Muscle fiber

Brief 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. 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.

Interventions

PROCEDUREwhole-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.

Sponsors

University of Erlangen-Nürnberg Medical School
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* 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)

Exclusion criteria

* 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 * 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

Design outcomes

Primary

MeasureTime frameDescription
Differences in Myosin isoforms8 weeksThe Myosin isoforms in the muscle biopsies will be determined by protein expression analysis via Western Blotting.
Differences in Force development and Calcium 2+ sensitivity of single muscle fibers8 weeksForce 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 pathways8 weeksSignaling 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.
Differences in Myosin:Actin ratio8 weeksMyosin:Actin ratio in the muscle biopsies assessed by protein analysis via Western Blotting.
Differences in cellular ultra structures8 weeksCellular ultra structures in the muscle biopsies will be examined using multi-photon microscopy.

Secondary

MeasureTime frameDescription
Differences in Nutritional risk0 weekNutritional Risk Screening-2002
Differences in inflammatory status0 weekPro-inflammatory cytokines

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026