Screening to Predict Weight Loss in Patients With Cancer
|ClinicalTrials.gov Identifier: NCT00710632|
Recruitment Status : Unknown
Verified July 2009 by National Cancer Institute (NCI).
Recruitment status was: Active, not recruiting
First Posted : July 4, 2008
Last Update Posted : September 17, 2013
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.
|Condition or disease||Intervention/treatment|
|Cachexia Gastrointestinal Cancer Hematopoietic/Lymphoid Cancer Lung Cancer Unspecified Adult Solid Tumor, Protocol Specific||Other: laboratory biomarker analysis Other: physiologic testing Other: questionnaire administration Procedure: management of therapy complications|
- 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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||220 participants|
|Primary Purpose:||Supportive Care|
|Official Title:||Predicting Weight Loss in People With Cancer: Development of a Screening Tool|
|Study Start Date :||September 2007|
|Estimated Primary Completion Date :||August 2008|
- 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00710632
|Queen's Medical Centre|
|Nottingham, England, United Kingdom, NG7 2UH|
|Principal Investigator:||Vanessa Halliday, MSC||University of Nottingham|