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

Completed

• Conditions: Cachexia

• Registration Number: NCT01533909
• Lead Sponsor: Universitaire Ziekenhuizen KU 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.

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 Timeline

• Study First Submitted: 2012-02-10
• Study First Submitted QC: 2012-02-14
• Study First Posted: 2012-02-15
• Status Verified: 2012-03
• Study Start: 2012-03
• Primary Completion: 2013-05
• Study Completion: 2013-09
• Last Update Submitted: 2014-12-02
• Last Update Posted: 2014-12-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Nutritional Assessment	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

Name	Time	Method
Quality of Life	4 times in 6 months	The EORTC-QlQ questionnaire will be used to assess the quality of life of the participants.
Anthropometric measurements	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	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.

Trial Locations

Locations (1)

University Hospital Leuven; 🇧🇪 Leuven, Vlaams Brabant, Belgium