Clinical trial NCT00710632: Screening to Predict Weight Loss in Patients With Cancer
Official title: Predicting Weight Loss in People With Cancer: Development of a Screening Tool
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cachexia
Gastrointestinal Cancer
Hematopoietic/Lymphoid Cancer
Lung Cancer
Unspecified Adult Solid Tumor, Protocol Specific
Keywords: cachexia
lung cancer
gastrointestinal cancer
unspecified adult solid tumor, protocol specific
hematopoietic/lymphoid cancer
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2008-07-04
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility 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

Primary outcomes:
measure: Percentage weight loss by measuring height and weight at baseline and at 3 months
measure: Malnutrition Universal Screening Tool Score at initial screening
measure: Response to the Appetite and Symptom Questionnaire at baseline
measure: Level of blood C-reactive protein at baseline
measure: Clinical condition, defined as diagnosis and stage of disease, treatment, and performance status at baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Nottingham
country: United Kingdom
facility: Queen's Medical Centre
state: England
Study officials:
affiliation: University of Nottingham
name: Vanessa Halliday, MSC
role: PRINCIPAL_INVESTIGATOR
References: