Development of a Screening Tool to Detect and Stage Cachectic Cancer Patients
|ClinicalTrials.gov Identifier: NCT01533909|
Recruitment Status : Completed
First Posted : February 15, 2012
Last Update Posted : December 3, 2014
|Condition or disease|
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 :||Observational|
|Actual Enrollment :||56 participants|
|Official Title:||Development of a Screening Tool to Detect and Stage Cachectic Cancer Patients|
|Study Start Date :||March 2012|
|Actual Primary Completion Date :||May 2013|
|Actual Study Completion Date :||September 2013|
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.
- 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.
- Quality of Life [ Time Frame: 4 times in 6 months ]The EORTC-QlQ questionnaire will be used to assess the quality of life of the participants.
- Anthropometric measurements [ Time Frame: 4 times in 6 months ]
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.
- Markers of inflammation/metabolic disturbance [ Time Frame: 4 times in 6 months ]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.
Biospecimen Retention: Samples Without DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01533909
|University Hospital Leuven|
|Leuven, Vlaams Brabant, Belgium, 3000|
|Principal Investigator:||Ignace Vergote, PhD||Universitaire Ziekenhuizen Leuven|