- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00710632
Screening to Predict Weight Loss in Patients With Cancer
Predicting Weight Loss in People With Cancer: Development of a Screening Tool
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.
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
England
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Nottingham, England, United Kingdom, NG7 2UH
- Queen's Medical Centre
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Percentage weight loss by measuring height and weight at baseline and at 3 months
|
Malnutrition Universal Screening Tool Score at initial screening
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Response to the Appetite and Symptom Questionnaire at baseline
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Level of blood C-reactive protein at baseline
|
Clinical condition, defined as diagnosis and stage of disease, treatment, and performance status at baseline
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Vanessa Halliday, MSC, University of Nottingham
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CDR0000590278
- QMC-WEIGHT
- EU-20831
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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