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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00196885
First Posted: September 20, 2005
Last Update Posted: June 20, 2008
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.
Collaborator:
Heidelberg University
Information provided by:
German Cancer Research Center
September 12, 2005
September 20, 2005
June 20, 2008
December 2003
Not Provided
muscle cross-sectional area, peak forces
Same as current
Complete list of historical versions of study NCT00196885 on ClinicalTrials.gov Archive Site
  • muscle fiber composition (biopsy vastus lateralis muscle mRNA levels of cytokines, myostatin. Activity of Akt-dependent pathways
  • muscle 31Phospho-magnetic-resonance spectroscopy
  • muscle fiber composition (biopsy vastus lateralis muscle mRNA levels of cytokines, myostatin. Activity of Akt-dependent pathways
  • muscle 31Phopho-magnetic-resonance spectroscopy
Not Provided
Not Provided
 
Effect of an Antioxidant on Cancer-Cachectic Patients Undergoing Exercise Training
Effect of N-Acetylcysteine on Skeletal Muscle in Cachectic Cancer Patients Undergoing a Resistance Training Program (Phase 2 Study)
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
  • Gastrointestinal Neoplasms
  • Bronchial Carcinoma
  • Hodgkin Disease
  • Non-Hodgkin Lymphoma
  • Weight Loss
Drug: N-acetylcysteine
Not Provided
Hauer K, Hildebrandt W, Sehl Y, Edler L, Oster P, Dröge W. Improvement in muscular performance and decrease in tumor necrosis factor level in old age after antioxidant treatment. J Mol Med (Berl). 2003 Feb;81(2):118-25. Epub 2003 Feb 8.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
December 2006
Not Provided

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
Sexes Eligible for Study: All
20 Years to 80 Years   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
Germany
 
 
NCT00196885
whilde157/2003
Not Provided
Not Provided
Not Provided
Not Provided
German Cancer Research Center
Heidelberg University
Study Director: Wulf Hildebrandt, MD German Cancer Research Center
German Cancer Research Center
June 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP