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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01533909
Recruitment Status : Completed
First Posted : February 15, 2012
Last Update Posted : December 3, 2014
Information provided by (Responsible Party):
Universitaire Ziekenhuizen Leuven

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.

Condition or disease

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 : Observational
Actual Enrollment : 56 participants
Time Perspective: Cross-Sectional
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

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.

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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
The blood sample that will be collected is part of the routine hospital assessment. The biomarkers that will be measured are albumine, creatine, CRP, hemoglobin and Lactate dehydrogenase (LDH).

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 95 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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)

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01533909

University Hospital Leuven
Leuven, Vlaams Brabant, Belgium, 3000
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
Principal Investigator: Ignace Vergote, PhD Universitaire Ziekenhuizen Leuven

Responsible Party: Universitaire Ziekenhuizen Leuven Identifier: NCT01533909     History of Changes
Other Study ID Numbers: S54035
First Posted: February 15, 2012    Key Record Dates
Last Update Posted: December 3, 2014
Last Verified: March 2012

Additional relevant MeSH terms:
Weight Loss
Body Weight Changes
Body Weight
Signs and Symptoms