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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Primary purpose supportive care

Primary Outcomes

Percentage weight loss by measuring height and weight at baseline and at 3 months
time frame:
Malnutrition Universal Screening Tool Score at initial screening
time frame:
Response to the Appetite and Symptom Questionnaire at baseline
time frame:
Level of blood C-reactive protein at baseline
time frame:
Clinical condition, defined as diagnosis and stage of disease, treatment, and performance status at baseline
time frame:

Eligibility Criteria

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

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2013.
Information provided to ClinicalTrials.gov by National Cancer Institute (NCI).