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

This study has been completed.
Sponsor:
Collaborator:
University of Heidelberg
Information provided by:
German Cancer Research Center
ClinicalTrials.gov Identifier:
NCT00196885
First received: September 12, 2005
Last updated: June 18, 2008
Last verified: June 2008
History of Changes
  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 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:

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
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:

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
proteolysis

Additional relevant MeSH terms:
Neoplasms
Carcinoma
Carcinoma, Bronchogenic
Gastrointestinal Neoplasms
Digestive System Neoplasms
Hodgkin Disease
Lymphoma
Lymphoma, Non-Hodgkin
Weight Loss
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
 Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Digestive System Diseases
Gastrointestinal Diseases
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Body Weight Changes
Body Weight
Signs and Symptoms
Acetylcysteine
N-monoacetylcystine
Antiviral Agents

ClinicalTrials.gov processed this record on October 16, 2012