Laboratory biomarker analysis and questionnaire administration and physiologic testing in Lung Cancer and Unspecified Adult Solid Tumor, Protocol Specific and Cachexia - Clinical Trials Registry

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

220

Phase

Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United Kingdom
- England
  - Nottingham, England, United Kingdom, NG7 2UH
    - Queen's Medical Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Supportive Care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Queen's Medical Center

Investigators

Principal Investigator: Vanessa Halliday, MSC, University of Nottingham

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2007

Primary Completion (Anticipated)

August 1, 2008

Study Registration Dates

First Submitted

July 3, 2008

First Submitted That Met QC Criteria