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

This study has been completed.
Heidelberg University
Information provided by:
German Cancer Research Center
ClinicalTrials.gov Identifier:
First received: September 12, 2005
Last updated: June 18, 2008
Last verified: June 2008

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 2

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

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

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

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

German Cancer Research Center, D020
Heidelberg, Baden-Württemberg, Germany, 69120
Sponsors and Collaborators
German Cancer Research Center
Heidelberg University
Study Director: Wulf Hildebrandt, MD German Cancer Research Center
  More Information

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

Keywords provided by German Cancer Research Center:
cancer cachexia
muscle wasting
weight loss

Additional relevant MeSH terms:
Digestive System Neoplasms
Gastrointestinal Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Neoplasms by Site
Anti-Infective Agents
Antiviral Agents
Free Radical Scavengers
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on March 31, 2015