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

Cachexia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01533909
• Other study ID #: S54035
• Status: Completed
• Phase: N/A
• First received: February 10, 2012
• Last updated: December 2, 2014
• Start date: March 2012
• Est. completion date: September 2013

Study information

• Verified date: March 2012
• Source: Universitaire Ziekenhuizen Leuven
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: September 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 95 Years

Eligibility

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

Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Cachexia

Locations

Country	Name	City	State
Belgium	University Hospital Leuven	Leuven	Vlaams Brabant

Sponsors (1)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Nutritional Assessment	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.	4 times in 6 months	No
Secondary	Quality of Life	The EORTC-QlQ questionnaire will be used to assess the quality of life of the participants.	4 times in 6 months	No
Secondary	Anthropometric measurements	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.	4 times in 6 months	No
Secondary	Markers of inflammation/metabolic disturbance	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.	4 times in 6 months	No