Trial document





This trial has been registered retrospectively.
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  DRKS00005597

Trial Description

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Title

Comparison of different methods for measuring the nutritional status and the identification of malnutrition in patients with hematological and oncological diseases

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Trial Acronym

MEPO-Study

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URL of the Trial

http://-

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Brief Summary in Lay Language

In this study, various methods are tested, which are capable to diagnose malnutrition in patients with hematologic and oncologic diseases. The nutritional status will be assessed by three different methods: the Nutritional Risk Screening (NRS-2002), a comprehensive bioimpedance analysis (BIA) and the measurement of laboratory parameters that reflect the amount of visceral proteins in serum, such as albumin, prealbumin and retinol-binding protein. We want to investigate if these methods are suitable to detect the nutritional status of patients and diagnose malnutrition. In addition, the practicability of each method in clinical practice and the comparability of the methods should be evaluated.

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Brief Summary in Scientific Language

This is a single-center, non-interventional reliability study. The aim of the study is to make a statement about the applicability and comparability of different methods for detection of nutritional status and the identification of malnutrition in hematological and oncological patients. For this purpose bioimpedance analysis, laboratory parameters and Nutritional Risk Screening are conducted.

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Organizational Data

  •   DRKS00005597
  •   2014/02/17
  •   [---]*
  •   yes
  •   Approved
  •   2012-67, Ethikkommission der Medizinischen Fakultät der Martin-Luther-Universität Halle Wittenberg
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   C00-D48 -  Neoplasms
  •   D50-D90 -  Diseases of the blood and blood-forming organs and certain disorders involving the immune mechanism
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Interventions/Observational Groups

  •   The nutritional status of hematological and oncological patients will be assessed by bioimpedance analysis, Nutritional Risk Screening and laboratory parameters such as albumin, prealbumin and retinol-binding protein.
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Characteristics

  •   Non-interventional
  •   Other
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Diagnostic
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

Comparability of the methods used with regard to the detection of nutritional status and the identification of malnutrition in patients with hematologic and oncologic diseases.

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Secondary Outcome

Applicability of the methods in the clinical setting.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2012/08/15
  •   50
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

Patients who were hospitalized for the beginning or the continuation of chemotherapy, older than 18 years, patient should be able to understand and to answer the complete questionnaire, signed and dated consent form, patient should be able to give its consent

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Exclusion Criteria

Patients with known drug or alcohol dependency; patients with severe active infection; patients with severe chronic or infectious diseases (liver cirrhosis, hepatitis, rheumatism); abnormal laboratory values (ASAT >2,5x upper limit, ALAT >2,5x upper limit, creatinin >1,5x upper limit), patients with cardiac pacemaker, patients with heart defibrillator, patients with HIV/AIDS, patients with arm- or leg amputations, patients who receive parenteral nutrition, patients under dialysis treatment, patients with an impaired thyroid metabolism, patients where an exact height and weight determination is not possible

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Universitätsklinikum Halle (Saale)Klinik für Innere Medizin IVHämatologie und Onkologie
    • Mr.  Dr. med.  Jörn  Rüssel 
    • Ernst-Grube-Str. 40
    • 06120  Halle (Saale)
    • Germany
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    • Universitätsklinikum Halle (Saale) Klinik für Innere Medizin IVHämatologie und Onkologie
    • Ms.  M.Sc.   Camilla   Leithold 
    • Ernst-Grube-Str. 40
    • 06120  Halle (Saale)
    • Germany
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    • Universitätsklinikum Halle (Saale)Klinik für Innere Medizin IVHämatologie und Onkologie
    • Mr.  Dr. med.   Jörn  Rüssel 
    • Ernst-Grube-Str. 40
    • 06120  Halle (Saale)
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsklinikum Halle (Saale) Klinik für Innere Medizin IVHämatologie und Onkologie
    • Ernst-Grube-Str. 40
    • 06120  Halle (Saale)
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2013/01/07
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Trial Publications, Results and other Documents

  • [---]*
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* This entry means the parameter is not applicable or has not been set.