Clinical Trial: Development of a Screening Tool to Detect and Stage Cachectic Cancer Patients

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Development of a Screening Tool to Detect and Stage Cachectic Cancer Patients

Brief 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.

Detailed Summary:

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.


Sponsor: Universitaire Ziekenhuizen Leuven

Current 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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.


Original Secondary Outcome: Same as current

Information By: Universitaire Ziekenhuizen Leuven

Dates:
Date Received: February 10, 2012
Date Started: March 2012
Date Completion:
Last Updated: December 2, 2014
Last Verified: March 2012