Screening to Predict Weight Loss in Patients With Cancer
Primary Purpose
Cachexia, Gastrointestinal Cancer, Hematopoietic/Lymphoid Cancer
Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
laboratory biomarker analysis
physiologic testing
questionnaire administration
management of therapy complications
Sponsored by
About this trial
This is an interventional supportive care trial for Cachexia focused on measuring cachexia, lung cancer, gastrointestinal cancer, unspecified adult solid tumor, protocol specific, hematopoietic/lymphoid cancer
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
Sites / Locations
- Queen's Medical Centre
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
NCT ID
NCT00710632
First Posted
July 3, 2008
Last Updated
September 16, 2013
Sponsor
Queen's Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT00710632
Brief Title
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
2. Study Status
Record Verification Date
July 2009
Overall Recruitment Status
Unknown status
Study Start Date
September 2007 (undefined)
Primary Completion Date
August 2008 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Queen's Medical Center
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Enrollment
220 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Other
Intervention Name(s)
laboratory biomarker analysis
Intervention Type
Other
Intervention Name(s)
physiologic testing
Intervention Type
Other
Intervention Name(s)
questionnaire administration
Intervention Type
Procedure
Intervention Name(s)
management of therapy complications
Primary Outcome Measure Information:
Title
Percentage weight loss by measuring height and weight at baseline and at 3 months
Title
Malnutrition Universal Screening Tool Score at initial screening
Title
Response to the Appetite and Symptom Questionnaire at baseline
Title
Level of blood C-reactive protein at baseline
Title
Clinical condition, defined as diagnosis and stage of disease, treatment, and performance status at baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vanessa Halliday, MSC
Organizational Affiliation
University of Nottingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
Queen's Medical Centre
City
Nottingham
State/Province
England
ZIP/Postal Code
NG7 2UH
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
Screening to Predict Weight Loss in Patients With Cancer
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