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Completed

NCT Number: NCT00196885

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

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.

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Key information

Conditions

Gastrointestinal Neoplasms Atrophy Body Weight Body Weight Changes Bronchial Carcinoma Bronchial Neoplasms Carcinoma, Bronchogenic Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Hemic and Lymphatic Diseases Hodgkin Disease Immune System Diseases Immunoproliferative Disorders Lung Diseases Lung Neoplasms Lymphatic Diseases Lymphoma Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Muscular Atrophy Neoplasms Neoplasms by Histologic Type Neoplasms by Site Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Non-Hodgkin Lymphoma Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases Respiratory Tract Neoplasms Signs and Symptoms Thoracic Neoplasms Weight Loss

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

German Cancer Research Center, D020

Heidelberg, Baden-Wurttemberg, 69120, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

N-acetylcysteine

Drug

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

Sponsors and collaborators

Lead sponsor

German Cancer Research Center

Other

Collaborators

  • Heidelberg University

Registry information

Official study title

Effect of N-Acetylcysteine on Skeletal Muscle in Cachectic Cancer Patients Undergoing a Resistance Training Program (Phase 2 Study)

Important dates

Study start
2003
Study completion
2006
First posted
Sep 20, 2005
Registry last updated
Jun 20, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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