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Screening to Predict Weight Loss in Patients With Cancer

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2009 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00710632
First Posted: July 4, 2008
Last Update Posted: September 17, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Cancer Institute (NCI)
  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
  • 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

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00710632     History of Changes
Other Study ID Numbers: CDR0000590278
QMC-WEIGHT
EU-20831
First Submitted: July 3, 2008
First Posted: July 4, 2008
Last Update Posted: September 17, 2013
Last Verified: July 2009

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:
Weight Loss
Cachexia
Wasting Syndrome
Gastrointestinal Neoplasms
Body Weight Changes
Body Weight
Signs and Symptoms
Emaciation
Metabolic Diseases
Nutrition Disorders
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases