NCT01120483

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2006

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2006

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2007

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

May 6, 2010

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 11, 2010

Completed
Last Updated

May 11, 2010

Status Verified

October 1, 2006

Enrollment Period

6 months

First QC Date

May 6, 2010

Last Update Submit

May 10, 2010

Conditions

CancerMalnutrition

Keywords

mortalityfunctional status

Outcome Measures

Primary Outcomes (1)

  • Prevalence of malnutrition

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

    1 day

Secondary Outcomes (3)

  • Quality of life

    1 day

  • Mortality

    6 months

  • Depression

    1 day

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients will be selected in primary care clinics.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Gastroenterology, Charité Universitätsmedizin Berlin, Campus Mitte

Berlin, State of Berlin, 10117, Germany

Location

MeSH Terms

Conditions

NeoplasmsMalnutrition

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic Diseases

Study Officials

  • Matthias Pirlich, MD

    Charite University, Berlin, Germany

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 6, 2010

First Posted

May 11, 2010

Study Start

December 1, 2006

Primary Completion

June 1, 2007

Study Completion

June 1, 2007

Last Updated

May 11, 2010

Record last verified: 2006-10

Locations

DE(1)