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
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00710632
First received: July 3, 2008
Last updated: September 16, 2013
Last verified: July 2009
  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)
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.
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: September 16, 2013
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 July 24, 2014