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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00196885
First Posted: September 20, 2005
Last Update Posted: June 20, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Heidelberg University
Information provided by:
German Cancer Research Center
  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
Intervention Model: Parallel Assignment
Masking: Double
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
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00196885


Locations
Germany
German Cancer Research Center, D020
Heidelberg, Baden-Württemberg, Germany, 69120
Sponsors and Collaborators
German Cancer Research Center
Heidelberg University
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
First Submitted: September 12, 2005
First Posted: September 20, 2005
Last Update Posted: June 20, 2008
Last Verified: June 2008

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

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