Screening to Predict Weight Loss in Patients With Cancer
NCT ID: NCT00710632
Last Updated: 2013-09-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
220 participants
INTERVENTIONAL
2007-09-30
Brief Summary
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PURPOSE: This clinical trial is studying how well a new screening tool works in predicting weight loss in patients with cancer.
Detailed Description
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* 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
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Keywords
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Study Design
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SUPPORTIVE_CARE
Interventions
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laboratory biomarker analysis
physiologic testing
questionnaire administration
management of therapy complications
Eligibility Criteria
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Inclusion Criteria
* Meets 1 of the following criteria, depending on part of study:
* Part 1:
* Receiving radiotherapy for cancer at Nottingham City Hospital
* Likely to be clinically stable over the duration of one week (i.e., not at high risk of disease or treatment-related appetite and weight loss)
* Stable weight and appetite
* Part 2:
* Outpatient at Nottingham City Hospital with a confirmed diagnosis of primary lung or gastrointestinal cancer
* Lost no more than 10% of pre-illness stable body weight
* Lost no more than 5% of pre-illness stable body weight if body mass index (BMI) was less than 20 kg/m\^2
* BMI ≥ 18.5 kg/m\^2
PATIENT CHARACTERISTICS:
* No condition impairing the ability to swallow
* Not receiving enteral tube feeding or parenteral nutrition (part 2)
* Able to be weighed (part 2)
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* No concurrent radiotherapy to the head, neck or upper gastrointestinal tract area
18 Years
ALL
No
Sponsors
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Queen's Medical Center
OTHER
Principal Investigators
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Vanessa Halliday, MSC
Role: PRINCIPAL_INVESTIGATOR
University of Nottingham
Locations
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Queen's Medical Centre
Nottingham, England, United Kingdom
Countries
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Other Identifiers
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QMC-WEIGHT
Identifier Type: -
Identifier Source: secondary_id
EU-20831
Identifier Type: -
Identifier Source: secondary_id
CDR0000590278
Identifier Type: -
Identifier Source: org_study_id