NCT00710632

Screening to Predict Weight Loss in Patients With Cancer

Predicting Weight Loss in People With Cancer: Development of a Screening Tool

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 220 (estimated)
• Sponsor: Queen's Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Screening tests may identify people with cancer who are at high risk of losing weight and help doctors plan better treatment. PURPOSE: This clinical trial is studying how well a new screening tool works in predicting weight loss in patients with cancer.

Detailed description

OBJECTIVES: * To identify people with cancer who are at greatest risk of future weight loss by the development of a simple and practical screening tool. * To estimate the reliability of the Appetite and Symptom Questionnaire (part 1). * To develop a screening tool based on the ability of the optimal combination of items from the three measures (ASQ, MUST, CRP) to predict clinically significant weight loss over three months (part 2). * To estimate the sensitivity and specificity at various cut-points of the developed screening tool in predicting clinically significant weight loss (\> 10% weight loss or between 5% and 10% weight loss with a BMI \< 20 kg/m\^2) over three months (part 2). OUTLINE: This is a two-part study. * Part 1: Patients are asked to complete the Appetite and Symptom Questionnaire (ASQ) on two occasions, one week apart. * Part 2: Patients are screened at baseline for risk of malnutrition using the Malnutrition Universal Screening Tool. Blood samples are also taken at this time to establish the level of C-reactive protein and patients complete the ASQ. Patients are weighed using calibrated scales and height measurements are obtained. Patients are asked about unplanned weight loss over the previous 3-6 months. Patients are weighed again at 3 months. Percentage weight loss is calculated at 3 months.

Conditions

• Cachexia
• Gastrointestinal Cancer
• Hematopoietic/Lymphoid Cancer
• Lung Cancer
• Unspecified Adult Solid Tumor, Protocol Specific

Interventions

Type	Name	Description
OTHER	laboratory biomarker analysis
OTHER	physiologic testing
OTHER	questionnaire administration
PROCEDURE	management of therapy complications

Timeline

• Start date: 2007-09-01
• Primary completion: 2008-08-01
• First posted: 2008-07-04
• Last updated: 2013-09-17

Locations

1 site across 1 country: United Kingdom