- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03551990
Influence of Motor Proteins on Muscle Atrophy in Cancer Patients
May 28, 2018 updated by: University of Erlangen-Nürnberg Medical School
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
Intervention / Treatment
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:
- Yurdagül Zopf, Prof. Dr. med.
- Phone Number: +49 9131 85-45218
- Email: yurdaguel.zopf@k-erlangen.de
-
-
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- EMS Tumor Motor Proteins
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.
Clinical Trials on Cancer
-
University of Michigan Rogel Cancer CenterRecruitingCancer Liver | Cancer Brain | Cancer Head &Neck | Cancer PelvisUnited States
-
Cellworks Group Inc.RecruitingCancer | Relapsed Cancer | Refractory CancerUnited States
-
UNC Lineberger Comprehensive Cancer CenterHyundai Hope On WheelsRecruitingCancer | Pediatric Cancer | Survivorship | Cancer MetastaticUnited States
-
Vanderbilt-Ingram Cancer CenterNational Institutes of Health (NIH)Active, not recruitingAdvanced Cancer | Relapsed Cancer | Refractory CancerUnited States
-
City of Hope Medical CenterNational Cancer Institute (NCI)CompletedStage III Pancreatic Cancer | Stage IIA Pancreatic Cancer | Stage IIB Pancreatic Cancer | Stage IV Gastric Cancer | Stage IVA Colorectal Cancer | Stage IVA Pancreatic Cancer | Stage IVB Colorectal Cancer | Stage IVB Pancreatic Cancer | Stage IIIA Gastric Cancer | Stage IIIB Gastric Cancer | Stage IIIC Gastric... and other conditionsUnited States
-
MiRXES Pte LtdRecruitingBreast Cancer | Gastric Cancer | Colorectal Cancer | Pancreatic Cancer | Esophageal Cancer | Ovarian Cancer | Prostate Cancer | Thoracic Cancer | Liver CancerSingapore
-
Sidney Kimmel Cancer Center at Thomas Jefferson...CompletedStage I Breast Cancer | Stage I Uterine Corpus Cancer | Stage II Uterine Corpus Cancer | Stage III Uterine Corpus Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIA Breast Cancer | Stage IIB Breast Cancer | Stage... and other conditionsUnited States
-
Massachusetts General HospitalNational Comprehensive Cancer NetworkCompletedGastric Cancer | Pancreatic Cancer | Esophageal Cancer | Rectal Cancer | Colon Cancer | Hepatobiliary CancerUnited States
-
Johns Hopkins UniversityNational Cancer Institute (NCI); National Institute on Minority Health and...Enrolling by invitationCancer | Advanced Cancer | End Stage Cancer | MalignancyUnited States
-
University of California, San FranciscoBristol-Myers Squibb; PfizerTerminatedStage IIIA Rectal Cancer | Stage IIIB Rectal Cancer | Stage IIIC Rectal Cancer | Metastatic Colorectal Adenocarcinoma | Metastatic Colon Adenocarcinoma | Metastatic Rectal Adenocarcinoma | Stage IIIA Colon Cancer | Stage IIIB Colon Cancer | Stage IIIC Colon Cancer | Stage IV Colon Cancer | Stage IV Rectal... and other conditionsUnited States
Clinical Trials on whole-body electromyostimulation WB-EMS
-
University of Erlangen-Nürnberg Medical SchoolCompletedCancer | Muscle Weakness | Weight Loss | Cancer Cachexia | Muscle LossGermany
-
University of Erlangen-Nürnberg Medical SchoolUnknownGynecologic Cancer | CachexiaGermany
-
University of Erlangen-Nürnberg Medical SchoolCompletedMuscle Strength | Trunk Stability | Golf Specific PerformanceGermany
-
University of Erlangen-Nürnberg Medical SchoolUniversity of Erlangen-NürnbergWithdrawn
-
University of Erlangen-Nürnberg Medical SchoolUnknownMetabolic Syndrome | Overweight and ObesityGermany
-
Charite University, Berlin, Germanymiha bodytec GmbHUnknown
-
Universidad de LeónCompleted
-
University of Erlangen-Nürnberg Medical SchoolUnknownCancer | Muscle Weakness | Weight Loss | Cancer Cachexia | Muscle LossGermany
-
Federal University of Health Science of Porto AlegreLeonhardt Ventures LLCNot yet recruiting
-
University of Erlangen-Nürnberg Medical SchoolParacelsus Medical UniversityCompleted