- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01533909
Development of a Screening Tool to Detect and Stage Cachectic Cancer Patients
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Vlaams Brabant
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Leuven, Vlaams Brabant, Belgium, 3000
- University Hospital Leuven
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- New Diagnosed Patients With Primary Head and Neck Cancer Neoplasms
- New Diagnosed Patients With Metastatic Pancreatic Neoplasms
- New Diagnosed Patients With Metastatic Colonic Neoplasms
Exclusion Criteria:
- Patients With Other Primary Neoplasms
- Patients Already in Therapy
- Patients With Non-metastatic Colonic or Pancreatic Neoplasms
Study Plan
How is the study designed?
Design Details
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Nutritional Assessment
Time Frame: 4 times in 6 months
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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.
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4 times in 6 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Quality of Life
Time Frame: 4 times in 6 months
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The EORTC-QlQ questionnaire will be used to assess the quality of life of the participants.
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4 times in 6 months
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Anthropometric measurements
Time Frame: 4 times in 6 months
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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. |
4 times in 6 months
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Markers of inflammation/metabolic disturbance
Time Frame: 4 times in 6 months
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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.
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4 times in 6 months
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Collaborators and Investigators
Investigators
- Principal Investigator: Ignace Vergote, PhD, Universitaire Ziekenhuizen KU Leuven
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- S54035
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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