Influence of Motor Proteins on Muscle Atrophy in Cancer Patients

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 Overview

Status

Unknown

Conditions

Study Type

Interventional

Enrollment (Anticipated)

420

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Bavaria
      • Erlangen, Bavaria, Germany, 91054
        • Recruiting
        • Hector-Center for Nutrition, Exercise and Sports
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control group; patients without a tumor disease, surgery
Control group with patients without a tumor disease but with indication for surgery in close proximity to the M. rectus abdominis
No Intervention: Control group; tumor patients, surgery
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
Experimental: Intervention group; tumor patients, WB-EMS, surgery
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Differences in Myosin:Actin ratio
Time Frame: 8 weeks
Myosin:Actin ratio in the muscle biopsies assessed by protein analysis via Western Blotting.
8 weeks
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.
8 weeks
Differences in cellular ultra structures
Time Frame: 8 weeks
Cellular ultra structures in the muscle biopsies will be examined using multi-photon microscopy.
8 weeks
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.
8 weeks
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.
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Differences in inflammatory status
Time Frame: 0 week
Pro-inflammatory cytokines
0 week
Differences in Nutritional risk
Time Frame: 0 week
Nutritional Risk Screening-2002
0 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 31, 2017

Primary Completion (Anticipated)

December 1, 2021

Study Completion (Anticipated)

June 1, 2022

Study Registration Dates

First Submitted

May 10, 2017

First Submitted That Met QC Criteria

May 28, 2018

First Posted (Actual)

June 11, 2018

Study Record Updates

Last Update Posted (Actual)

June 11, 2018

Last Update Submitted That Met QC Criteria

May 28, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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