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CompletedNCT00196885Updated Jun 20, 2008

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

A Phase 2 interventional study of N-acetylcysteine in Gastrointestinal Neoplasms, Bronchial Carcinoma and Hodgkin Disease, sponsored by German Cancer Research Center. Completed at 1 site in Germany. Open to participants aged 20 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2008-06-20.

Sponsored by German Cancer Research Center · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
20 Years to 80 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Gastrointestinal Neoplasms
  • Bronchial Carcinoma
  • Hodgkin Disease
  • Non-Hodgkin Lymphoma
  • Weight Loss

Keywords

  • cancer cachexia
  • muscle wasting
  • weight loss
  • proteolysis
03

In context

Gastrointestinal Neoplasms

795 studies on the registry are indexed under Gastrointestinal Neoplasms; 235 are open to participants now.

This study's enrollment of 60 is close to the median of 60 across 580 interventional studies indexed under Gastrointestinal Neoplasms.

Browse Gastrointestinal Neoplasms studies →

Lead sponsor

German Cancer Research Center is the lead sponsor of 49 studies on the registry; 13 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • gastrointestinal or bronchial cancer
  • weight loss of 10% within 6 months
  • sufficient mobility

Exclusion criteria

Exclusion Criteria:

  • severe pain, steroid therapy, severe internal, muscular, neurological, psychiatric disease, N-acetylcysteine allergy
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double
Enrollment
60 participants

Interventions

06

What researchers measure

Primary outcomes

  1. muscle cross-sectional area, peak forces

Secondary outcomes

  1. muscle fiber composition (biopsy vastus lateralis muscle mRNA levels of cytokines, myostatin. Activity of Akt-dependent pathways

  2. muscle 31Phospho-magnetic-resonance spectroscopy

07

Study locations

1 site
  • German Cancer Research Center, D020
    Heidelberg, Baden-Wurttemberg 69120, Germany
08

References and documents

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 (Berl). 2003 Feb;81(2):118-25. doi: 10.1007/s00109-002-0406-7. Epub 2003 Feb 8. PubMed 12601528 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 20, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00196885
Lead sponsor
German Cancer Research Center
Collaborators
Heidelberg University
First posted
Sep 20, 2005
Start date
Dec 2003
Completion
Dec 2006
Last update
Jun 20, 2008

Study contacts

Wulf Hildebrandt, MD
study director · German Cancer Research Center
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2008. You cannot join it, but the record below documents what was studied.

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