CachexiaNCT00710632
Screening to Predict Weight Loss in Patients With Cancer
A study testing laboratory biomarker analysis, physiologic testing and questionnaire administration in people with Cachexia and Gastrointestinal Cancer, run by Queen's Medical Center at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cachexia, Gastrointestinal Cancer, Hematopoietic/Lymphoid Cancer
- What is being tested?
- laboratory biomarker analysis, physiologic testing and questionnaire administration
- Type of treatment
- Surgery or procedure
- How many people
- 220 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2007to Aug 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Queen's Medical Centre
Nottingham, England, NG7 2UH
About this study
Official title: 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.
Read the 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.
- Conditions
- Cachexia, Gastrointestinal Cancer, Hematopoietic/Lymphoid Cancer, Lung Cancer, Unspecified Adult Solid Tumor, Protocol Specific
- Being tested
- laboratory biomarker analysis, physiologic testing, questionnaire administration, management of therapy complications
- Keywords
- cachexia, lung cancer, gastrointestinal cancer, unspecified adult solid tumor, protocol specific, hematopoietic/lymphoid cancer
- Medical subject headings
- Cachexia, Gastrointestinal Neoplasms, Hematologic Neoplasms, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laboratory biomarker analysisOther
physiologic testingOther
questionnaire administrationOther
management of therapy complicationsProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2008 (estimated)
- Study startSep 2007
- Primary completionAug 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CachexiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Queen's Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Vanessa Halliday, MSC, Principal investigator, University of Nottingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00710632
- Sponsor's protocol ID
- CDR0000590278
- Other IDs
- QMC-WEIGHT, EU-20831
- Status last verified
- Jul 2009
- First submitted
- 3 Jul 2008
- Last updated
- 17 Sep 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predicting Weight Loss in People With Cancer: Development of a Screening Tool
- ClinicalTrials.gov ID
- NCT00710632
- Acronym / sponsor ID
- CDR0000590278
- 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
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Queen's Medical CenterUniversity, hospital or other
- Study start
- Sep 2007
- Primary completion
- Aug 2008 (estimated)
- First posted
- 4 Jul 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| laboratory biomarker analysis | Other | – |
| physiologic testing | Other | – |
| questionnaire administration | Other | – |
| management of therapy complications | Procedure or surgery | – |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vanessa Halliday, MSC principal investigator
University of Nottingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing laboratory biomarker analysis, physiologic testing and questionnaire administration in people with Cachexia and Gastrointestinal Cancer, run by Queen's Medical Center at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage weight loss by measuring height and weight at baseline and at 3 months. The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2013.