Screening to Predict Weight Loss in Patients With Cancer
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|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||Phase|
|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||Not Applicable|
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|