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

Information provided by German Cancer Research Center
Information obtained from ClinicalTrials.gov on 2006-12-08
Link to the current ClinicalTrials.gov record.

Condition(s) treated: Gastrointestinal Neoplasms; Bronchial Carcinoma; Hodgkin Disease; Non-Hodgkin Lymphoma; Weight Loss

Intervention: N-acetylcysteine (Drug)

Phase: Phase 2

Enrollment status: Recruiting. Expecting to enroll 60 people.

Sponsor: German Cancer Research Center

Principal investigator(s) or official(s):
Wulf Hildebrandt, MD, Study Director, Affiliation: German Cancer Research Center

Overall contact:
Lutz Edler, Dr., Phone: 0049 6221 422392, Email: l.edler@dkfz.de

Summary

The purpose of the study is to tests the hypthesis, 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.

Clinical Details

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

Study design: Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: muscle cross-sectional area, peak forces

Secondary outcome: muscle fiber composition (biopsy vastus lateralis muscle mRNA levels of cytokines, myostatin. Activity of Akt-dependent pathways; muscle 31Phopho-magnetic-resonance spectroscopy

Eligibility

Minimum eligible age: 20 Years. Maximum eligible age: 80 Years. Eligible gender(s): Both.

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

Locations and Contact Information

Lutz Edler, Dr., Phone: 0049 6221 422392, Email: l.edler@dkfz.de

German Cancer Research Center, D020, Heidelberg, Baden-Württemberg 69120, Germany; Recruiting
Wulf Hildebrandt, MD, Priv.-Doz. Dr. Med, Phone: 0049 6221 423749, Email: w.hildebrandt@dkfz.de
Holger Krakowski-Roosen, Dr., Phone: 0049 6221 423243, Email: h.krakowski-roosen@dkfz.de
Wulf Hildebrandt, MD, Principal Investigator

Additional Information

Related 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. 2003 Feb;81(2):118-25. Epub 2003 Feb 8.

Start date: December 2003
End date: December 2008
Last updated: May 8, 2006

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