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

NCT00196885 | Completed Phase 2

• 1 other identifier: whilde157/2003
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

cancer cachexia; muscle wasting; weight loss; proteolysis

Outcome Measures

Primary Outcomes (1)

• muscle cross-sectional area, peak forces

Secondary Outcomes (2)

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

• muscle 31Phospho-magnetic-resonance spectroscopy

Interventions

N-acetylcysteine DRUG

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• German Cancer Research Center: lead
• Heidelberg University: collaborator

Study Sites (1)

German Cancer Research Center, D020

Heidelberg, Baden-Wurttemberg, 69120, Germany

Location

Related Publications (1)

• 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.

  PMID: 12601528 BACKGROUND

MeSH Terms

Conditions

Gastrointestinal Neoplasms; Carcinoma, Bronchogenic; Hodgkin Disease; Lymphoma, Non-Hodgkin; Weight Loss; Muscular Atrophy

Interventions

Acetylcysteine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Cysteine; Amino Acids, Sulfur; Sulfur Compounds; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Wulf Hildebrandt, MD

  German Cancer Research Center

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 20, 2005
• Study Start: December 1, 2003
• Study Completion: December 1, 2006
• Last Updated: June 20, 2008

Record last verified: 2008-06

Locations

DE (1)