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


N/A
18 Years
N/A
Open (Enrolling)
Both
Cachexia, Gastrointestinal Cancer, Hematopoietic/Lymphoid Cancer, Lung Cancer, Unspecified Adult Solid Tumor, Protocol Specific

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Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Supportive Care

Outcome Measure:

Percentage weight loss by measuring height and weight at baseline and at 3 months

Safety Issue:

No

Principal Investigator

Vanessa Halliday, MSC

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Nottingham

Authority:

United States: Federal Government

Study ID:

CDR0000590278

NCT ID:

NCT00710632

Start Date:

September 2007

Completion Date:

Related Keywords:

  • Cachexia
  • Gastrointestinal Cancer
  • Hematopoietic/Lymphoid Cancer
  • Lung Cancer
  • Unspecified Adult Solid Tumor, Protocol Specific
  • cachexia
  • lung cancer
  • gastrointestinal cancer
  • unspecified adult solid tumor, protocol specific
  • hematopoietic/lymphoid cancer
  • Cachexia
  • Lung Neoplasms
  • Weight Loss
  • Gastrointestinal Neoplasms

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