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

Primary Purpose

Gastrointestinal Neoplasms, Bronchial Carcinoma, Hodgkin Disease

Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
N-acetylcysteine
Sponsored by
German Cancer Research Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastrointestinal Neoplasms focused on measuring cancer cachexia, muscle wasting, weight loss, proteolysis

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • German Cancer Research Center, D020

Outcomes

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

Full Information

First Posted
September 12, 2005
Last Updated
June 18, 2008
Sponsor
German Cancer Research Center
Collaborators
Heidelberg University
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1. Study Identification

Unique Protocol Identification Number
NCT00196885
Brief Title
Effect of an Antioxidant on Cancer-Cachectic Patients Undergoing Exercise Training
Official Title
Effect of N-Acetylcysteine on Skeletal Muscle in Cachectic Cancer Patients Undergoing a Resistance Training Program (Phase 2 Study)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2008
Overall Recruitment Status
Completed
Study Start Date
December 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
German Cancer Research Center
Collaborators
Heidelberg University

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastrointestinal Neoplasms, Bronchial Carcinoma, Hodgkin Disease, Non-Hodgkin Lymphoma, Weight Loss
Keywords
cancer cachexia, muscle wasting, weight loss, proteolysis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
60 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
N-acetylcysteine
Primary Outcome Measure Information:
Title
muscle cross-sectional area, peak forces
Secondary Outcome Measure Information:
Title
muscle fiber composition (biopsy vastus lateralis muscle mRNA levels of cytokines, myostatin. Activity of Akt-dependent pathways
Title
muscle 31Phospho-magnetic-resonance spectroscopy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wulf Hildebrandt, MD
Organizational Affiliation
German Cancer Research Center
Official's Role
Study Director
Facility Information:
Facility Name
German Cancer Research Center, D020
City
Heidelberg
State/Province
Baden-Württemberg
ZIP/Postal Code
69120
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
12601528
Citation
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 (Berl). 2003 Feb;81(2):118-25. doi: 10.1007/s00109-002-0406-7. Epub 2003 Feb 8.
Results Reference
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Effect of an Antioxidant on Cancer-Cachectic Patients Undergoing Exercise Training

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