Screening to Predict Weight Loss in Patients With Cancer

Not Applicable

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

• Registration Number: NCT00710632
• Lead Sponsor: Queen's Medical Center

Brief 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.

Study Timeline

• Study Start: 2007-09
• Study First Submitted: 2008-07-03
• Study First Submitted QC: 2008-07-03
• Study First Posted: 2008-07-04
• Primary Completion: 2008-08
• Status Verified: 2009-07
• Last Update Submitted: 2013-09-16
• Last Update Posted: 2013-09-17

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 220

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage weight loss by measuring height and weight at baseline and at 3 months
Malnutrition Universal Screening Tool Score at initial screening
Response to the Appetite and Symptom Questionnaire at baseline
Level of blood C-reactive protein at baseline
Clinical condition, defined as diagnosis and stage of disease, treatment, and performance status at baseline

Trial Locations

Locations (1)

Queen's Medical Centre; 🇬🇧 Nottingham, England, United Kingdom