Screening to Predict Weight Loss in Patients With Cancer
The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2009 by National Cancer Institute (NCI).
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
Queen's Medical Centre
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00710632
First received: July 3, 2008
Last updated: July 9, 2009
Last verified: July 2009
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Cachexia Gastrointestinal Cancer Hematopoietic/Lymphoid Cancer Lung Cancer Unspecified Adult Solid Tumor, Protocol Specific |
Other: laboratory biomarker analysis Other: physiologic testing Other: questionnaire administration Procedure: management of therapy complications |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Supportive Care |
| Official Title: | Predicting Weight Loss in People With Cancer: Development of a Screening Tool |
Resource links provided by NLM:
Further study details as provided by National Cancer Institute (NCI):
Primary Outcome Measures:
- Percentage weight loss by measuring height and weight at baseline and at 3 months [ Designated as safety issue: No ]
- Malnutrition Universal Screening Tool Score at initial screening [ Designated as safety issue: No ]
- Response to the Appetite and Symptom Questionnaire at baseline [ Designated as safety issue: No ]
- Level of blood C-reactive protein at baseline [ Designated as safety issue: No ]
- Clinical condition, defined as diagnosis and stage of disease, treatment, and performance status at baseline [ Designated as safety issue: No ]
| Estimated Enrollment: | 220 |
| Study Start Date: | September 2007 |
| Estimated Primary Completion Date: | August 2008 (Final data collection date for primary outcome measure) |
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00710632
Locations
| United Kingdom | |
| Queen's Medical Centre | |
| Nottingham, England, United Kingdom, NG7 2UH | |
Sponsors and Collaborators
Queen's Medical Centre
Investigators
| Principal Investigator: | Vanessa Halliday, MSC | University of Nottingham |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00710632 History of Changes |
| Other Study ID Numbers: | CDR0000590278, QMC-WEIGHT, EU-20831 |
| Study First Received: | July 3, 2008 |
| Last Updated: | July 9, 2009 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
cachexia lung cancer gastrointestinal cancer unspecified adult solid tumor, protocol specific hematopoietic/lymphoid cancer |
Additional relevant MeSH terms:
|
Cachexia Lung Neoplasms Weight Loss Gastrointestinal Neoplasms Emaciation Body Weight Changes Body Weight Signs and Symptoms Respiratory Tract Neoplasms |
Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Digestive System Neoplasms Digestive System Diseases Gastrointestinal Diseases |
ClinicalTrials.gov processed this record on May 16, 2013