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Strength Training on Pancreatic Cancer (STOPC)

This study has suspended participant recruitment.
Sponsor:
Collaborators:
University of Heidelberg
Technische Universität München
Information provided by:
German Cancer Research Center
ClinicalTrials.gov Identifier:
NCT01395563
First received: December 4, 2009
Last updated: July 14, 2011
Last verified: July 2011
History of Changes
  Purpose

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).


Condition Intervention
Pancreatic Neoplasms
Cachexia
Myopathy
 Behavioral: strength training

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Strength Training on Pancreatic Cancer

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by German Cancer Research Center:

Primary Outcome Measures:
  • muscle mass and strength [ Time Frame: after 8 weeks of intervention ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • quality of life [ Time Frame: after 8 weeks of intervention ] [ Designated as safety issue: No ]

Estimated Enrollment: 58
Study Start Date: January 2009
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
pancreatic cancer patients
 Behavioral: strength training
strength training, high intensity, twice up to 3 times per week
Other Names:
  • progressive resistance training
  • sports
  • muscle hypertrophia
  • cachexia
Experimental: 2
pancreatic cancer patients
 Behavioral: strength training
strength training, high intensity, twice up to 3 times per week
Other Names:
  • progressive resistance training
  • sports
  • muscle hypertrophia
  • cachexia

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

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01395563

Locations
Germany
German Cancer Research Center
Heidelberg, Germany, 69120
European Pancreas Center
Heidelberg, Germany, 69120
Technische Universität München
Munich, Germany, 81675
Sponsors and Collaborators
German Cancer Research Center
University of Heidelberg
Technische Universität München
Investigators
Principal Investigator: Jens Werner, Prof. Dr. med. University of Heidelberg
Principal Investigator: Holger Krakowski-Roosen, Dr. German CRC
Principal Investigator: Marc Martignoni, PD Dr. med. Technische Universität München
  More Information

No publications provided

Responsible Party: Krakowski-Roosen, Dr., German Cancer Research Center
ClinicalTrials.gov Identifier: NCT01395563     History of Changes
Other Study ID Numbers: GermanCRC
Study First Received: December 4, 2009
Last Updated: July 14, 2011
Health Authority: Germany: Ethics Commission

Additional relevant MeSH terms:
Cachexia
Neoplasms
Muscular Diseases
Pancreatic Neoplasms
Emaciation
Weight Loss
Body Weight Changes
Body Weight
Signs and Symptoms
 Musculoskeletal Diseases
Neuromuscular Diseases
Nervous System Diseases
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 21, 2013