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

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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

This Tabular View shows the required WHO registration data elements as marked by ^†

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 ^†

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.