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Effect of an Antioxidant on Cancer-Cachectic Patients Undergoing Exercise Training

This study has been completed.
Study NCT00196885.   Last updated on June 18, 2008.   Information provided by German Cancer Research Center

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Descriptive Information Fields
Brief Title  Effect of an Antioxidant on Cancer-Cachectic Patients Undergoing Exercise Training
Official Title  Effect of N-Acetylcysteine on Skeletal Muscle in Cachectic Cancer Patients Undergoing a Resistance Training Program (Phase 2 Study)
Brief Summary

The purpose of the study is to tests the hypothesis, that N-acetylcysteine (a thiol-antioxidant)improves the exercise training effect on cancer patients that experience weight loss (cachexia) as assessed by muscle mass and function as well as histomorphology.

Detailed Description
Study Phase Phase II
Study Type  Interventional
Study Design  Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary Outcome Measure  muscle cross-sectional area, peak forces
Secondary Outcome Measure  muscle fiber composition (biopsy vastus lateralis muscle mRNA levels of cytokines, myostatin. Activity of Akt-dependent pathways
muscle 31Phospho-magnetic-resonance spectroscopy
Condition  Gastrointestinal Neoplasms
Bronchial Carcinoma
Hodgkin Disease
Non-Hodgkin Lymphoma
Weight Loss
Intervention  Drug: N-acetylcysteine
MEDLINE PMIDs 12601528
Links
Recruitment Information Fields
Recruitment Status  Completed
Enrollment  60
Start Date  December 2003
Completion Date December 2006
Eligibility Criteria 

Inclusion Criteria:

  • gastrointestinal or bronchial cancer
  • weight loss of 10% within 6 months
  • sufficient mobility

Exclusion Criteria:

  • severe pain, steroid therapy, severe internal, muscular, neurological, psychiatric disease, N-acetylcysteine allergy
Gender Both
Ages 20 Years to 80 Years
Accepts Healthy Volunteers Yes
Contacts ††
Location Countries  Germany
Administrative Information Fields
NCT ID  NCT00196885
Organization ID whilde157/2003
Secondary IDs ††
Study Sponsor  German Cancer Research Center
Collaborators †† University of Heidelberg
Investigators 
Study Director:     Wulf Hildebrandt, MD     German Cancer Research Center    
Information Provided By German Cancer Research Center
Verification Date June 2008
First Received Date  September 12, 2005
Last Updated Date June 18, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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