Prevalence of Malnutrition in Oncologic Patients

This study has been completed.
Sponsor:
Information provided by:
Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT01120483
First received: May 6, 2010
Last updated: May 10, 2010
Last verified: October 2006
  Purpose

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.

Hypothesis:

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
Cancer
Malnutrition

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prevalence and Impact of Malnutrition in Hospitalised Patients

Resource links provided by NLM:


Further study details as provided by Charite University, Berlin, Germany:

Primary Outcome Measures:
  • Prevalence of malnutrition [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    Phase angle (bioelectrical impedance analysis) Nutritional status(SGA), muscle function (grip strength)


Secondary Outcome Measures:
  • Quality of life [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    Quality of life is determined with the questionnaire QLQ C-30 of the European Organisation for Research and Treatment of Cancer (EORTC)

  • Mortality [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Patients are going to be contacted via telephone six months after the first assessment. Deceased patients will be determined by the local death register

  • Depression [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    Risk for depression is assessed using the Center for Epidemiological Studies Depression Scale (CES-D)


Enrollment: 400
Study Start Date: December 2006
Study Completion Date: June 2007
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients will be selected in primary care clinics.

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01120483

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

No publications provided

Responsible Party: Kristina Norman, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT01120483     History of Changes
Other Study ID Numbers: Onco400
Study First Received: May 6, 2010
Last Updated: May 10, 2010
Health Authority: Germany: Ethics Commission

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

Additional relevant MeSH terms:
Malnutrition
Nutrition Disorders

ClinicalTrials.gov processed this record on July 29, 2014