CachexiaNCT01533909
Development of a Screening Tool to Detect and Stage Cachectic Cancer Patients
An observational study of Cachexia, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
The aim of the study is to develop a screenings tool that will enable hospital nurses to detect and stage cancer cachectic patients. The early detection and staging of cancer cachexia will assist the oncology team in providing the cachectic cancer patient tailor-made patient care. Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Cachexia
- How many people
- 56 participants
- Where
- 1 siteBelgium
- Study dates
- Mar 2012to Sep 2013
- 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 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The population from which the groups or cohorts will be selected (e.g., primary care clinic, community sample, residents of a certain town). (Limit: 1000 characters)
Who may be able to join
- New Diagnosed Patients With Primary Head and Neck Cancer Neoplasms
- New Diagnosed Patients With Metastatic Pancreatic Neoplasms
- New Diagnosed Patients With Metastatic Colonic Neoplasms
Who cannot join
- Patients With Other Primary Neoplasms
- Patients Already in Therapy
- Patients With Non-metastatic Colonic or Pancreatic Neoplasms
Trial locations and contacts
1 site in 1 country.
About this study
The aim of the study is to develop a screenings tool that will enable hospital nurses to detect and stage cancer cachectic patients. The early detection and staging of cancer cachexia will assist the oncology team in providing the cachectic cancer patient tailor-made patient care.
Read the detailed description
In this cross-sectional study, the participants will complete 4 times a set of questionnaires and measurements. The data that will be collected is:
age; sex; height; weight; type of tumour; classification of malignant tumours (TNM); progression of tumour and used therapy; blood sample to analyse albumin, creatine, hemoglobin, LDH and CRP; use of parental nutrition; dietary assessment; use of nutritional supplements; Quality of Life by using the EORTC-QlQ; Subjective Global Assessment; presence of Percutaneous endoscopic gastrostomy; use of enteral or parenteral nutrition; body composition based on a Bio Impedance Assessment; hand grip strength and mid upper arm circumference. Based on all these data points a easy to use tool/score for a hospital setting will be created. During the first assessment the measurements will be done in the morning and the evening to test the reproducibility.
- Conditions
- Cachexia
- Medical subject headings
- Cachexia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cancer patients | As this is not an intervention study there is only one cohort. Patients that will be included and excluded are described in the eligibility section. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nutritional Assessment
Patient-Generated Subjective Global Assessment Instrument is a measure for the nutritional status of the participants. The final score of this instruments devides participants into three categories: well-nourished, moderately nourished or suspected malnourished.
Measured: 4 times in 6 months
Secondary outcomes (3)
Quality of Life
The EORTC-QlQ questionnaire will be used to assess the quality of life of the participants.
Measured: 4 times in 6 months
Anthropometric measurements
Mid-upper arm circumference will be measured to have an idea of the muscle mass.
Hand Grip Strength will be measured to obtain an idea of the muscle strength. Weight will be measured during every occasion. Question will be asked about weight loss during the last 6 months. Body composition will be measured by Bio-impedance assessment to obtain an indication of the fat-free mass.
Changes of all these measurements will be monitored.
Measured: 4 times in 6 months
Markers of inflammation/metabolic disturbance
Biomarkers will be selected as part of the routine hospital assessment. These markers are C-reactief proteïne, albumin, creatinin, hemoglobin and Lactate dehydrogenase (LDH). These markers are a measure of the nutritional status and are seen as markers for the catabolic state of cachectic cancer patients.
Measured: 4 times in 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2012 (estimated)
- Study startMar 2012
- Primary completionMay 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CachexiaStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe 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
- Time perspective
- Cross-sectional
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ignace Vergote, PhD, Principal investigator, Universitaire Ziekenhuizen KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01533909
- Sponsor's protocol ID
- S54035
- Status last verified
- Mar 2012
- First submitted
- 10 Feb 2012
- Last updated
- 3 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Screening Tool to Detect and Stage Cachectic Cancer Patients
- ClinicalTrials.gov ID
- NCT01533909
- Acronym / sponsor ID
- S54035
- Conditions
- Cachexia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- May 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 15 Feb 2012 (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.
The aim of the study is to develop a screenings tool that will enable hospital nurses to detect and stage cancer cachectic patients. The early detection and staging of cancer cachexia will assist the oncology team in providing the cachectic cancer patient tailor-made patient care.
Detailed description
In this cross-sectional study, the participants will complete 4 times a set of questionnaires and measurements. The data that will be collected is:
age; sex; height; weight; type of tumour; classification of malignant tumours (TNM); progression of tumour and used therapy; blood sample to analyse albumin, creatine, hemoglobin, LDH and CRP; use of parental nutrition; dietary assessment; use of nutritional supplements; Quality of Life by using the EORTC-QlQ; Subjective Global Assessment; presence of Percutaneous endoscopic gastrostomy; use of enteral or parenteral nutrition; body composition based on a Bio Impedance Assessment; hand grip strength and mid upper arm circumference. Based on all these data points a easy to use tool/score for a hospital setting will be created. During the first assessment the measurements will be done in the morning and the evening to test the reproducibility.
Study design
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cancer patients | – | –As this is not an intervention study there is only one cohort. Patients that will be included and excluded are described in the eligibility section. |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The population from which the groups or cohorts will be selected (e.g., primary care clinic, community sample, residents of a certain town). (Limit: 1000 characters)
Key inclusion criteria (3 listed)
- New Diagnosed Patients With Primary Head and Neck Cancer Neoplasms
- New Diagnosed Patients With Metastatic Pancreatic Neoplasms
- New Diagnosed Patients With Metastatic Colonic Neoplasms
Key exclusion criteria (3 listed)
- Patients With Other Primary Neoplasms
- Patients Already in Therapy
- Patients With Non-metastatic Colonic or Pancreatic Neoplasms
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
Nutritional Assessment
Time frame: 4 times in 6 months
Patient-Generated Subjective Global Assessment Instrument is a measure for the nutritional status of the participants. The final score of this instruments devides participants into three categories: well-nourished, moderately nourished or suspected malnourished.
3 secondary outcomes
Quality of Life
Time frame: 4 times in 6 months
Anthropometric measurements
Time frame: 4 times in 6 months
Markers of inflammation/metabolic disturbance
Time frame: 4 times in 6 months
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 3 Dec 2014.
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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.
Ignace Vergote, PhD principal investigator
Universitaire Ziekenhuizen KU Leuven
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 Cachexia, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
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 3 inclusion and 3 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 3 Dec 2014. 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 Belgium. 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?
Nutritional Assessment (time frame: 4 times in 6 months). 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 3 Dec 2014.