Prevalence of Malnutrition in Oncologic Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01120483
Recruitment Status : Completed
First Posted : May 11, 2010
Last Update Posted : May 11, 2010
Information provided by:
Charite University, Berlin, Germany

Brief Summary:

Malnutrition is a common phenomenon in cancer patients. Deteriorated nutritional status is associated with poor clinical outcome. The purpose of this study is to determine the prevalence of hospital malnutrition and its impact on functionality, quality of life and mortality in cancer patients and to test the reference percentiles of phase angle values (Bosy Westphal et al JPEN 2006) as indicator of cancer cachexia and predictor of mortality.


The fifth reference percentile of the phase angle norm values is a prognostically relevant cut off value indicating cancer cachexia in terms of malnutrition, fatigue and impaired functional status, as well as predictive of 6-month mortality

Condition or disease
Cancer Malnutrition

Study Type : Observational
Actual Enrollment : 400 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prevalence and Impact of Malnutrition in Hospitalised Patients
Study Start Date : December 2006
Actual Primary Completion Date : June 2007
Actual Study Completion Date : June 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malnutrition
U.S. FDA Resources

Primary Outcome Measures :
  1. Prevalence of malnutrition [ Time Frame: 1 day ]
    Phase angle (bioelectrical impedance analysis) Nutritional status(SGA), muscle function (grip strength)

Secondary Outcome Measures :
  1. Quality of life [ Time Frame: 1 day ]
    Quality of life is determined with the questionnaire QLQ C-30 of the European Organisation for Research and Treatment of Cancer (EORTC)

  2. Mortality [ Time Frame: 6 months ]
    Patients are going to be contacted via telephone six months after the first assessment. Deceased patients will be determined by the local death register

  3. Depression [ Time Frame: 1 day ]
    Risk for depression is assessed using the Center for Epidemiological Studies Depression Scale (CES-D)

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients will be selected in primary care clinics.

Inclusion Criteria:

  • Patients suffering from cancer.
  • Patients who have signed a written Informed Consent.

Exclusion Criteria:

  • Patients with implanted pacemaker or defibrillator
  • Patients with neuromuscular disease or hemiplegia.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01120483

Department of Gastroenterology, Charité Universitätsmedizin Berlin, Campus Mitte
Berlin, Germany, 10117
Sponsors and Collaborators
Charite University, Berlin, Germany
Principal Investigator: Matthias Pirlich, MD Charite University, Berlin, Germany

Responsible Party: Kristina Norman, Charite University, Berlin, Germany Identifier: NCT01120483     History of Changes
Other Study ID Numbers: Onco400
First Posted: May 11, 2010    Key Record Dates
Last Update Posted: May 11, 2010
Last Verified: October 2006

Keywords provided by Charite University, Berlin, Germany:
functional status

Additional relevant MeSH terms:
Nutrition Disorders