Strength Training on Pancreatic Cancer (STOPC)

March 12, 2015 updated by: German Cancer Research Center
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).

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Heidelberg, Germany, 69120
        • German Cancer Research Center
      • Heidelberg, Germany, 69120
        • European Pancreas Center
      • Munich, Germany, 81675
        • Technische Universität München

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
muscle mass and strength
Time Frame: after 8 weeks of intervention
after 8 weeks of intervention

Secondary Outcome Measures

Outcome Measure
Time Frame
quality of life
Time Frame: after 8 weeks of intervention
after 8 weeks of intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

German Cancer Research Center

Collaborators

Heidelberg University
Technical University of Munich

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., Technical University of Munich

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (Anticipated)

December 1, 2011

Study Completion (Anticipated)

December 1, 2011

Study Registration Dates

First Submitted

December 4, 2009

First Submitted That Met QC Criteria

July 14, 2011

First Posted (Estimate)

July 15, 2011

Study Record Updates

Last Update Posted (Estimate)

March 13, 2015

Last Update Submitted That Met QC Criteria

March 12, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GermanCRC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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