Screening to Predict Weight Loss in Patients With Cancer

Study Overview
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Brief Summary
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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
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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.

Official Title
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Predicting Weight Loss in People With Cancer: Development of a Screening Tool

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

Intervention / Treatment
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* Other: laboratory biomarker analysis
* Other: physiologic testing
* Other: questionnaire administration
* Procedure: management of therapy complications


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care


Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: laboratory biomarker analysis|nan|
|Other: physiologic testing|nan|
|Other: questionnaire administration|nan|
|Procedure: management of therapy complications|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cachexia, lung cancer, gastrointestinal cancer, unspecified adult solid tumor, protocol specific, hematopoietic/lymphoid cancer