Strength Training on Pancreatic Cancer (STOPC)
Primary Purpose
Pancreatic Neoplasms, Cachexia, Myopathy
Status
Withdrawn
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
strength training
Sponsored by
About this trial
This is an interventional treatment trial for Pancreatic Neoplasms
Eligibility Criteria
Inclusion Criteria:
- patients with pancreatic carcinomas after surgery (resection or exploration)
- given consent
Exclusion Criteria:
- acute infection
- pain
- no mobility or ability for walking or standing
- severe neurological disorders (apoplex, morbus Parkinson, paresis of the lower extremeties)
- severe cardiac or cardiovascular diseases (z.B. heart insufficiency NYHA III, myocardial infarction <3 months)
- rhytmical disorders, that contraindicate ergospirometric examinations
- cardiac therapy with digitalis pharmacy
- unclear syncopes
- severe pulmonal insufficiency
- renal insufficiency (GFR < 30% at Krea >3 mg/dl)
- synchronous participation in an other clinical trial
Sites / Locations
- European Pancreas Center
- German Cancer Research Center
- Technische Universität München
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
1
2
Arm Description
pancreatic cancer patients
pancreatic cancer patients
Outcomes
Primary Outcome Measures
muscle mass and strength
Secondary Outcome Measures
quality of life
Full Information
NCT ID
NCT01395563
First Posted
December 4, 2009
Last Updated
March 12, 2015
Sponsor
German Cancer Research Center
Collaborators
Heidelberg University, Technical University of Munich
1. Study Identification
Unique Protocol Identification Number
NCT01395563
Brief Title
Strength Training on Pancreatic Cancer
Acronym
STOPC
Official Title
Strength Training on Pancreatic Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
March 2015
Overall Recruitment Status
Withdrawn
Study Start Date
January 2009 (undefined)
Primary Completion Date
December 2011 (Anticipated)
Study Completion Date
December 2011 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
German Cancer Research Center
Collaborators
Heidelberg University, Technical University of Munich
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to determine whether prednisone, methotrexate, and cyclophosphamide are effective in the treatment of rapidly progressive hearing loss in both ears due to autoimmune inner ear disease (AIED).
Detailed Description
Sudden out-of-hospital cardiac arrest (OOH-CA) remains a significant cause of death, in spite of recent declines in overall mortality from cardiovascular disease. Existing methods of emergency resuscitation are inadequate due to time delays inherent in the transport of a trained responder with defibrillation capabilities to the side of the OOH-CA victim. Existing Emergency Medical Services (EMS) systems typically combine paramedic Emergency Medical Technician (EMT) services with some level of community involvement, such as bystander cardiopulmonary resuscitation (CPR) training. Some communities include automated external defibrillators (AEDs) at isolated sites or in mobile police or fire vehicles. A comprehensive, integrated community approach to treatment with AEDs would have community units served by these volunteer non-medical responders who can quickly identify and treat a patient with OOH-CA. Such an approach is termed Public Access Defibrillation (PAD).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Neoplasms, Cachexia, Myopathy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
pancreatic cancer patients
Arm Title
2
Arm Type
Experimental
Arm Description
pancreatic cancer patients
Intervention Type
Behavioral
Intervention Name(s)
strength training
Other Intervention Name(s)
progressive resistance training, sports, muscle hypertrophia, cachexia
Intervention Description
strength training, high intensity, twice up to 3 times per week
Primary Outcome Measure Information:
Title
muscle mass and strength
Time Frame
after 8 weeks of intervention
Secondary Outcome Measure Information:
Title
quality of life
Time Frame
after 8 weeks of intervention
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients with pancreatic carcinomas after surgery (resection or exploration)
given consent
Exclusion Criteria:
acute infection
pain
no mobility or ability for walking or standing
severe neurological disorders (apoplex, morbus Parkinson, paresis of the lower extremeties)
severe cardiac or cardiovascular diseases (z.B. heart insufficiency NYHA III, myocardial infarction <3 months)
rhytmical disorders, that contraindicate ergospirometric examinations
cardiac therapy with digitalis pharmacy
unclear syncopes
severe pulmonal insufficiency
renal insufficiency (GFR < 30% at Krea >3 mg/dl)
synchronous participation in an other clinical trial
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jens Werner, Prof. Dr. med.
Organizational Affiliation
Heidelberg University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Holger Krakowski-Roosen, Dr.
Organizational Affiliation
German CRC
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Marc Martignoni, PD Dr. med.
Organizational Affiliation
Technical University of Munich
Official's Role
Principal Investigator
Facility Information:
Facility Name
European Pancreas Center
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Facility Name
German Cancer Research Center
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Facility Name
Technische Universität München
City
Munich
ZIP/Postal Code
81675
Country
Germany
12. IPD Sharing Statement
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Strength Training on Pancreatic Cancer
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