Screening to Predict Weight Loss in Patients With Cancer
This trial is active, not recruiting.
|Conditions||cachexia, gastrointestinal cancer, hematopoietic/lymphoid cancer, lung cancer, unspecified adult solid tumor, protocol specific|
|Treatments||laboratory biomarker analysis, physiologic testing, questionnaire administration, management of therapy complications|
|Sponsor||Queen's Medical Centre|
|Start date||September 2007|
|End date||August 2008|
|Trial size||220 participants|
|Trial identifier||NCT00710632, CDR0000590278, EU-20831, QMC-WEIGHT|
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.
|Primary purpose||supportive care|
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
Male or female participants at least 18 years old.
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
|Official title||Predicting Weight Loss in People With Cancer: Development of a Screening Tool|
|Principal investigator||Vanessa Halliday, MSC|
|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.|
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