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NCT00196885 Clinical Trial

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

Weight Loss Clinical Trial

Official title:
Effect of N-Acetylcysteine on Skeletal Muscle in Cachectic Cancer Patients Undergoing a Resistance Training Program (Phase 2 Study)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00196885
Other study ID # whilde157/2003
Secondary ID
Status Completed
Phase Phase 2
First received September 12, 2005
Last updated June 18, 2008
Start date December 2003
Est. completion date December 2006

Study information
Verified date June 2008
Source German Cancer Research Center
Contact n/a
Is FDA regulated No
Health authority Germany: Federal Institute for Drugs and Medical Devices
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 60
Est. completion date December 2006
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 20 Years to 80 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• N-acetylcysteine

Locations
Country Name City State
Germany German Cancer Research Center, D020 Heidelberg Baden-Württemberg

Sponsors (2)
Lead Sponsor Collaborator
German Cancer Research Center Heidelberg University

Country where clinical trial is conducted

Germany, 

References & Publications (1)

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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary muscle cross-sectional area, peak forces
Secondary muscle fiber composition (biopsy vastus lateralis muscle mRNA levels of cytokines, myostatin. Activity of Akt-dependent pathways
Secondary muscle 31Phospho-magnetic-resonance spectroscopy
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