CancerNCT01120483
Prevalence of Malnutrition in Oncologic Patients
An observational study of Cancer and Malnutrition, run by Charite University, Berlin, Germany at 1 site in Germany.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Malnutrition
- How many people
- 400 participants
- Where
- 1 siteGermany
- Study dates
- Dec 2006to Jun 2007
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients will be selected in primary care clinics.
Who may be able to join
- Patients suffering from cancer.
- Patients who have signed a written Informed Consent.
Who cannot join
- Patients with implanted pacemaker or defibrillator
- Patients with neuromuscular disease or hemiplegia.
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Gastroenterology, Charité Universitätsmedizin Berlin, Campus Mitte
Berlin, State of Berlin, 10117
About this study
Official title: Prevalence and Impact of Malnutrition in Hospitalised 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
- Conditions
- Cancer, Malnutrition
- Keywords
- mortality, functional status
- Medical subject headings
- Neoplasms, Malnutrition
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of malnutrition
Phase angle (bioelectrical impedance analysis) Nutritional status(SGA), muscle function (grip strength)
Measured: 1 day
Secondary outcomes (3)
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)
Measured: 1 day
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
Measured: 6 months
Depression
Risk for depression is assessed using the Center for Epidemiological Studies Depression Scale (CES-D)
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2010 (estimated)
- Study startDec 2006
- Primary completionJun 2007
- Study completionJun 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Investigators
- Matthias Pirlich, MD, Principal investigator, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01120483
- Sponsor's protocol ID
- Onco400
- Status last verified
- Oct 2006
- First submitted
- 6 May 2010
- Last updated
- 11 May 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence and Impact of Malnutrition in Hospitalised Patients
- ClinicalTrials.gov ID
- NCT01120483
- Acronym / sponsor ID
- Onco400
- Conditions
- Cancer, Malnutrition
- Keywords
- mortality, functional status
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- Dec 2006
- Primary completion
- Jun 2007 (actual)
- Study completion
- Jun 2007 (actual)
- First posted
- 11 May 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients will be selected in primary care clinics.
Key inclusion criteria (2 listed)
- Patients suffering from cancer.
- Patients who have signed a written Informed Consent.
Key exclusion criteria (2 listed)
- Patients with implanted pacemaker or defibrillator
- Patients with neuromuscular disease or hemiplegia.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prevalence of malnutrition
Time frame: 1 day
Phase angle (bioelectrical impedance analysis) Nutritional status(SGA), muscle function (grip strength)
3 secondary outcomes
Quality of life
Time frame: 1 day
Mortality
Time frame: 6 months
Depression
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthias Pirlich, MD principal investigator
Charite University, Berlin, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer and Malnutrition, run by Charite University, Berlin, Germany at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 May 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of malnutrition (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2010.