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

NCT ID: NCT00196885

Last Updated: 2008-06-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-12-31

Study Completion Date

2006-12-31

Brief Summary

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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

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Conditions

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

Keywords

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cancer cachexia muscle wasting weight loss proteolysis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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N-acetylcysteine

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Heidelberg University

OTHER

Sponsor Role collaborator

German Cancer Research Center

OTHER

Sponsor Role lead

Principal Investigators

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Wulf Hildebrandt, MD

Role: STUDY_DIRECTOR

German Cancer Research Center

Locations

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German Cancer Research Center, D020

Heidelberg, Baden-Wurttemberg, Germany

Site Status

Countries

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Germany

References

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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.

Reference Type BACKGROUND
PMID: 12601528 (View on PubMed)

Other Identifiers

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whilde157/2003

Identifier Type: -

Identifier Source: org_study_id