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Strength Training on Pancreatic Cancer (STOPC)

This study has been withdrawn prior to enrollment.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01395563
First Posted: July 15, 2011
Last Update Posted: March 13, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Heidelberg University
Technische Universität München
Information provided by:
German Cancer Research Center
  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
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Strength Training on Pancreatic Cancer

Resource links provided by NLM:


Further study details as provided by German Cancer Research Center:

Primary Outcome Measures:
  • muscle mass and strength [ Time Frame: after 8 weeks of intervention ]

Secondary Outcome Measures:
  • quality of life [ Time Frame: after 8 weeks of intervention ]

Enrollment: 0
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

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01395563


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

Responsible Party: Krakowski-Roosen, Dr., German Cancer Research Center
ClinicalTrials.gov Identifier: NCT01395563     History of Changes
Other Study ID Numbers: GermanCRC
First Submitted: December 4, 2009
First Posted: July 15, 2011
Last Update Posted: March 13, 2015
Last Verified: March 2015

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