Prevalence of Malnutrition in Oncologic Patients

Cancer Clinical Trial

Official title:

Prevalence and Impact of Malnutrition in Hospitalised Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01120483
• Other study ID #: Onco400
• Status: Completed
• Phase: N/A
• First received: May 6, 2010
• Last updated: May 10, 2010
• Start date: December 2006
• Est. completion date: June 2007

Study information

• Verified date: October 2006
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: June 2007
• Est. primary completion date: June 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cancer
• Malnutrition

Locations

Country	Name	City	State
Germany	Department of Gastroenterology, Charité Universitätsmedizin Berlin, Campus Mitte	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of malnutrition	Phase angle (bioelectrical impedance analysis) Nutritional status(SGA), muscle function (grip strength)	1 day	No
Secondary	Quality of life	Quality of life is determined with the questionnaire QLQ C-30 of the European Organisation for Research and Treatment of Cancer (EORTC)	1 day	No
Secondary	Mortality	Patients are going to be contacted via telephone six months after the first assessment. Deceased patients will be determined by the local death register	6 months	No
Secondary	Depression	Risk for depression is assessed using the Center for Epidemiological Studies Depression Scale (CES-D)	1 day	No