Screening to Predict Weight Loss in Patients With Cancer

Queen's Medical Center

Status: Unknown

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

Treatments: Other: questionnaire administration; Other: physiologic testing; Other: laboratory biomarker analysis; Procedure: management of therapy complications

Study type: Interventional

Funder types: Other

Identifiers

NCT00710632

CDR0000590278

QMC-WEIGHT

EU-20831

Details and patient eligibility

About

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.

Full 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.

Enrollment: 220 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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