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Completed

NCT Number: NCT01533909

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

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.

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Key information

Conditions

Cachexia Body Weight Body Weight Changes Pathological Conditions, Signs and Symptoms Signs and Symptoms Thinness Weight Loss

Age range

18 year–95 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Leuven

Leuven, Vlaams Brabant, 3000, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Registry information

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Feb 15, 2012
Registry last updated
Dec 3, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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