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Clinical Trial 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.


Clinical Trial 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. ;


Study Design

Primary Purpose: Supportive Care


Related Conditions & MeSH terms


NCT number NCT00710632
Study type Interventional
Source National Cancer Institute (NCI)
Contact
Status Active, not recruiting
Phase N/A
Start date September 2007

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