Clinical trial NCT01395563: Strength Training on Pancreatic Cancer
Official title: Strength Training on Pancreatic Cancer
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Pancreatic Neoplasms
Cachexia
Myopathy
Lead sponsor: German Cancer Research Center
Sponsor class: OTHER
Collaborators: name: Heidelberg University
name: Technical University of Munich
First posted: 2011-07-15
Enrollment: 0
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: muscle mass and strength
timeFrame: after 8 weeks of intervention
Secondary outcomes:
measure: quality of life
timeFrame: after 8 weeks of intervention
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: European Pancreas Center
city: Heidelberg
country: Germany
facility: German Cancer Research Center
city: Munich
country: Germany
facility: Technische Universität München
Study officials:
affiliation: Heidelberg University
name: Jens Werner, Prof. Dr. med.
role: PRINCIPAL_INVESTIGATOR
affiliation: German CRC
name: Holger Krakowski-Roosen, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Technical University of Munich
name: Marc Martignoni, PD Dr. med.
role: PRINCIPAL_INVESTIGATOR
References: