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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by Universitaire Ziekenhuizen Leuven.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier:
NCT01533909
First received: February 10, 2012
Last updated: March 29, 2012
Last verified: March 2012
  Purpose

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
Cachexia

Study Type: Observational
Study Design: Time Perspective: Cross-Sectional
Official Title: Development of a Screening Tool to Detect and Stage Cachectic Cancer Patients

Resource links provided by NLM:


Further study details as provided by Universitaire Ziekenhuizen Leuven:

Primary Outcome Measures:
  • Nutritional Assessment [ Time Frame: 4 times in 6 months ] [ Designated as safety issue: No ]
    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:
  • Quality of Life [ Time Frame: 4 times in 6 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]
    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).


Estimated Enrollment: 300
Study Start Date: March 2012
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 95 Years
Genders Eligible for Study:   Both
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)

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01533909

Contacts
Contact: Christophe Matthys, PhD +3216342655 christophe.matthys@uzleuven.be
Contact: Ann Meulemans, PhD +3216 344714 ann.meulemans@uzleuven.be

Locations
Belgium
University Hospital Leuven Recruiting
Leuven, Vlaams Brabant, Belgium, 3000
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
Investigators
Principal Investigator: Ignace Vergote, PhD Universitaire Ziekenhuizen Leuven
  More Information

No publications provided

Responsible Party: Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT01533909     History of Changes
Other Study ID Numbers: S54035
Study First Received: February 10, 2012
Last Updated: March 29, 2012
Health Authority: Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment

ClinicalTrials.gov processed this record on October 23, 2014