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

Phase 2

Completed

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

• Registration Number: NCT00196885
• Lead Sponsor: German Cancer Research Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-12
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-20
• Study Completion: 2006-12
• Status Verified: 2008-06
• Last Update Submitted: 2008-06-18
• Last Update Posted: 2008-06-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
muscle cross-sectional area, peak forces

Secondary Outcome Measures

Name	Time	Method
muscle fiber composition (biopsy vastus lateralis muscle mRNA levels of cytokines, myostatin. Activity of Akt-dependent pathways
muscle 31Phospho-magnetic-resonance spectroscopy

Trial Locations

Locations (1)

German Cancer Research Center, D020; 🇩🇪 Heidelberg, Baden-Württemberg, Germany