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

This study has been completed.

First Received: September 12, 2005 Last Updated: June 18, 2008 History of Changes

Sponsor:	German Cancer Research Center
Collaborator:	University of Heidelberg
Information provided by:	German Cancer Research Center
ClinicalTrials.gov Identifier:	NCT00196885

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

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)

Resource links provided by NLM:

MedlinePlus related topics: Antioxidants Cancer Exercise and Physical Fitness Hodgkin Disease Lymphoma Weight Control

Drug Information available for: Acetylcysteine

U.S. FDA Resources

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
Study First Received:	September 12, 2005
Last Updated:	June 18, 2008
ClinicalTrials.gov Identifier:	NCT00196885 History of Changes
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by German Cancer Research Center:

cancer cachexia
muscle wasting
weight loss
proteolysis

Additional relevant MeSH terms:

Thoracic Neoplasms
Anti-Infective Agents
Respiratory System Agents
Antioxidants
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Diseases
Physiological Effects of Drugs
Body Weight
Signs and Symptoms
Neoplasms by Site
Respiratory Tract Diseases
Lung Neoplasms
Therapeutic Uses
Free Radical Scavengers
Weight Loss

Body Weight Changes
Acetylcysteine
Lymphoma
Hodgkin Disease
Antidotes
Respiratory Tract Neoplasms
Neoplasms by Histologic Type
Digestive System Neoplasms
Immunoproliferative Disorders
Immune System Diseases
Protective Agents
Antiviral Agents
Pharmacologic Actions
Carcinoma
Lymphatic Diseases

ClinicalTrials.gov processed this record on November 09, 2009