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

Purpose

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.

Condition	Intervention	Phase
Gastrointestinal Neoplasms Bronchial Carcinoma Hodgkin Disease Non-Hodgkin Lymphoma Weight Loss	Drug: N-acetylcysteine	Phase II

MedlinePlus related topics:

Antioxidants Cancer Exercise and Physical Fitness Hodgkin's Disease Lymphoma Weight Control

ChemIDplus related topics:

Acetylcysteine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

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

Further study details as provided by German Cancer Research Center:

Primary Outcome Measures:

muscle cross-sectional area, peak forces

Secondary Outcome Measures:

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

Estimated Enrollment:	60
Study Start Date:	December 2003
Study Completion Date:	December 2006

Eligibility

Ages Eligible for Study:	20 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00196885

Locations


Germany, Baden-Württemberg
	German Cancer Research Center, D020
	Heidelberg, Baden-Württemberg, Germany, 69120

Sponsors and Collaborators

German Cancer Research Center

University of Heidelberg

Investigators


Study Director:	Wulf Hildebrandt, MD	German Cancer Research Center

More Information

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.

Study ID Numbers:	whilde157/2003
First Received:	September 12, 2005
Last Updated:	June 18, 2008
ClinicalTrials.gov Identifier:	NCT00196885
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by German Cancer Research Center:

cancer cachexia

muscle wasting

weight loss

proteolysis

Study placed in the following topic categories:

Thoracic Neoplasms

Hodgkin's disease

Gastrointestinal Diseases

Hodgkin lymphoma, adult

Lymphoma, small cleaved-cell, diffuse

Cachexia

Body Weight

Signs and Symptoms

Respiratory Tract Diseases

Lung Neoplasms

Weight Loss

Body Weight Changes

Acetylcysteine

Hodgkin Disease

Lymphoma

Muscular Atrophy

Digestive System Neoplasms

Immunoproliferative Disorders

Carcinoma

Lymphatic Diseases

Digestive System Diseases

Lung Diseases

Gastrointestinal Neoplasms

Carcinoma, Bronchogenic

Lymphoma, Non-Hodgkin

Lymphoproliferative Disorders

N-monoacetylcystine

Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Anti-Infective Agents

Respiratory Tract Neoplasms

Respiratory System Agents

Neoplasms by Histologic Type

Antioxidants

Immune System Diseases

Molecular Mechanisms of Pharmacological Action

Physiological Effects of Drugs

Protective Agents

Antiviral Agents

Pharmacologic Actions

Neoplasms

Neoplasms by Site

Expectorants

Therapeutic Uses

Free Radical Scavengers

Antidotes

ClinicalTrials.gov processed this record on August 28, 2008

Sponsors and Collaborators:	German Cancer Research Center University of Heidelberg
Information provided by:	German Cancer Research Center
ClinicalTrials.gov Identifier:	NCT00196885