Screening to Predict Weight Loss in Patients With Cancer

Lung Cancer Clinical Trial

Official title:

Predicting Weight Loss in People With Cancer: Development of a Screening Tool

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00710632
• Other study ID #: CDR0000590278
• Secondary ID: QMC-WEIGHTEU-208
• Status: Active, not recruiting
• Phase: N/A
• First received: July 3, 2008
• Last updated: September 16, 2013
• Start date: September 2007

Study information

• Verified date: July 2009
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 220
• Est. primary completion date: August 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Cachexia
• Gastrointestinal Cancer
• Gastrointestinal Neoplasms
• Hematopoietic/Lymphoid Cancer
• Lung Cancer
• Unspecified Adult Solid Tumor, Protocol Specific

Intervention

Other:
• laboratory biomarker analysis

• physiologic testing

• questionnaire administration

Procedure:
• management of therapy complications

Locations

Country	Name	City	State
United Kingdom	Queen's Medical Centre	Nottingham	England

Sponsors (1)

Lead Sponsor	Collaborator
Queen's Medical Centre

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage weight loss by measuring height and weight at baseline and at 3 months			No
Primary	Malnutrition Universal Screening Tool Score at initial screening			No
Primary	Response to the Appetite and Symptom Questionnaire at baseline			No
Primary	Level of blood C-reactive protein at baseline			No
Primary	Clinical condition, defined as diagnosis and stage of disease, treatment, and performance status at baseline			No