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

Tracking Information

First Received Date ^ICMJE

September 12, 2005

Last Updated Date

June 18, 2008

Start Date ^ICMJE

December 2003

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

muscle cross-sectional area, peak forces

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00196885 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

muscle fiber composition (biopsy vastus lateralis muscle mRNA levels of cytokines, myostatin. Activity of Akt-dependent pathways
muscle 31Phospho-magnetic-resonance spectroscopy

Original Secondary Outcome Measures ^ICMJE

muscle fiber composition (biopsy vastus lateralis muscle mRNA levels of cytokines, myostatin. Activity of Akt-dependent pathways
muscle 31Phopho-magnetic-resonance spectroscopy

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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 ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Gastrointestinal Neoplasms
Bronchial Carcinoma
Hodgkin Disease
Non-Hodgkin Lymphoma
Weight Loss

Intervention ^ICMJE

Drug: N-acetylcysteine

Study Arms / Comparison Groups

Publications *

Hauer K, Hildebrandt W, Sehl Y, Edler L, Oster P, Droge W. Improvement in muscular performance and decrease in tumor necrosis factor level in old age after antioxidant treatment. J Mol Med. 2003 Feb;81(2):118-25. Epub 2003 Feb 8.

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

December 2006

Primary Completion Date

Eligibility Criteria ^ICMJE

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 ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Germany

Administrative Information

NCT ID ^ICMJE

NCT00196885

Responsible Party

Study ID Numbers ^ICMJE

whilde157/2003

Study Sponsor ^ICMJE

German Cancer Research Center

Collaborators ^ICMJE

University of Heidelberg

Investigators ^ICMJE

Study Director:

Wulf Hildebrandt, MD

German Cancer Research Center

Information Provided By

German Cancer Research Center

Verification Date

June 2008

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