Cachexia, Gastrointestinal Cancer, Hematopoietic/Lymphoid Cancer, Lung Cancer, Unspecified Adult Solid Tumor, Protocol Specific
Conditions
Keywords
cachexia, lung cancer, gastrointestinal cancer, unspecified adult solid tumor, protocol specific, hematopoietic/lymphoid cancer
Brief summary
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
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.
Interventions
OTHERlaboratory biomarker analysis
OTHERphysiologic testing
OTHERquestionnaire administration
PROCEDUREmanagement of therapy complications
Sponsors
Queen's Medical Center
Study design
Primary purpose
SUPPORTIVE_CARE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| Measure | 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 | — |
Countries
United Kingdom
Outcome results
None listed