Screening to Predict Weight Loss in Patients With Cancer

Queen's Medical Center220 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Purpose

SUPPORTIVE_CARE

Enrollment

220

Conditions

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

Interventions

laboratory biomarker analysisOTHER

physiologic testingOTHER

questionnaire administrationOTHER

management of therapy complicationsPROCEDURE

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Queen's Medical Centre

Nottingham, England, United Kingdom

Outcomes

Primary Outcomes

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

Data from ClinicalTrials.gov

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