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Completed

NCT Number: NCT01120483

Prevalence of Malnutrition in Oncologic Patients

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

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Key information

Conditions

Cancer Malnutrition Neoplasms Nutrition Disorders Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Gastroenterology, Charité Universitätsmedizin Berlin, Campus Mitte

Berlin, State of Berlin, 10117, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Prevalence of malnutrition

    Time frame: 1 day

    Phase angle (bioelectrical impedance analysis) Nutritional status(SGA), muscle function (grip strength)

Secondary outcomes

  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)

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Registry information

Official study title

Prevalence and Impact of Malnutrition in Hospitalised Patients

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
May 11, 2010
Registry last updated
May 11, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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