Strength Training on Pancreatic Cancer

Pancreatic Neoplasms Clinical Trial

— STOPC  

Official title:

Strength Training on Pancreatic Cancer

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01395563
• Other study ID #: GermanCRC
• Status: Withdrawn
• Phase: N/A
• First received: December 4, 2009
• Last updated: March 12, 2015
• Start date: January 2009
• Est. completion date: December 2011

Study information

• Verified date: March 2015
• Source: German Cancer Research Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cachexia
• Myopathy
• Pancreatic Neoplasms

Intervention

Behavioral:
• strength training
strength training, high intensity, twice up to 3 times per week

Locations

Country	Name	City	State
Germany	European Pancreas Center	Heidelberg
Germany	German Cancer Research Center	Heidelberg
Germany	Technische Universität München	Munich

Sponsors (3)

Lead Sponsor	Collaborator
German Cancer Research Center	Heidelberg University, Technische Universität München

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	muscle mass and strength		after 8 weeks of intervention	No
Secondary	quality of life		after 8 weeks of intervention	No