Prevalence of Malnutrition in Oncologic Patients

Completed

• Conditions: Cancer; Malnutrition

• Registration Number: NCT01120483
• Lead Sponsor: 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.

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2006-10
• Study Start: 2006-12
• Primary Completion: 2007-06
• Study Completion: 2007-06
• Study First Submitted: 2010-05-06
• Study First Submitted QC: 2010-05-10
• Last Update Submitted: 2010-05-10
• Study First Posted: 2010-05-11
• Last Update Posted: 2010-05-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 400

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Prevalence of malnutrition	1 day	Phase angle (bioelectrical impedance analysis) Nutritional status(SGA), muscle function (grip strength)

Secondary Outcome Measures

Name	Time	Method
Quality of life	1 day	Quality of life is determined with the questionnaire QLQ C-30 of the European Organisation for Research and Treatment of Cancer (EORTC)
Mortality	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
Depression	1 day	Risk for depression is assessed using the Center for Epidemiological Studies Depression Scale (CES-D)

Trial Locations

Locations (1)

Department of Gastroenterology, Charité Universitätsmedizin Berlin, Campus Mitte; 🇩🇪 Berlin, Germany