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An Observation of the Change in Percent Lean Body Mass of Stage III Non-Small Cell Lung Cancer Undergoing Radiation Treatment


N/A
50 Years
75 Years
Not Enrolling
Both
Lung Cancer, Malnutrition, Weight Changes

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Trial Information

An Observation of the Change in Percent Lean Body Mass of Stage III Non-Small Cell Lung Cancer Undergoing Radiation Treatment


OBJECTIVES:

Primary

- To determine energy and protein consumption on an average radiotherapy treatment day
using the multiple pass method 24-hour analysis of food recall at baseline and
treatment end.

- To compare energy and protein by mouth intake from baseline to treatment end.

- To measure and compare diet quality from baseline to radiotherapy treatment end by
Healthy Eating Index (HEI) score.

- To determine lean body mass versus fat mass using a bioelectrical impedance analysis
machine.

- To compare body fat to lean body mass percentage at baseline with that at radiotherapy
treatment end.

- To correlate energy and protein consumption with lean body mass at baseline and
treatment end.

- To determine the change in appetite throughout radiotherapy by comparing data obtained
by interview at baseline and radiotherapy treatment end.

- To determine the change in performance level (Karnofsky percentage) associated with the
radiotherapy through a series of questions asked at baseline and treatment end.

OUTLINE: Patients receive radiotherapy as planned for 7 weeks. Patients undergo an interview
on treatment day 1 (before initiation of radiotherapy) and treatment day 35 (after
completion of radiotherapy) regarding recent food consumption history and appetite.
Patients' standing weight and height are measured on these days and their body composition,
measured with a bioelectrical impedance analysis (BIA) device, are also taken. Patients'
Karnofsky performance score are obtained from their medical record.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Diagnosed with stage III non-small cell lung cancer (NSCLC)

- Plan to begin radiotherapy for NSCLC

- Radiotherapy is the only planned therapy for this cancer

- No brain metastases

PATIENT CHARACTERISTICS:

Inclusion criteria:

- Must be able to stand without assistance

Exclusion criteria:

- Unable to comply with study requirements

- Native language other than American English

- Pacemaker or implanted defibrillator

PRIOR CONCURRENT THERAPY:

Exclusion criteria:

- Receiving chemotherapy in combination with radiotherapy

- Concurrent megace or steroids

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Energy and protein consumption measured on an average radiotherapy treatment day by multiple pass method 24-hour analysis for food recall at baseline and treatment end

Principal Investigator

Jessica Stauffer, BS

Investigator Role:

Study Chair

Investigator Affiliation:

Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center

Authority:

United States: Federal Government

Study ID:

CASE5506

NCT ID:

NCT00530205

Start Date:

February 2007

Completion Date:

Related Keywords:

  • Lung Cancer
  • Malnutrition
  • Weight Changes
  • weight changes
  • malnutrition
  • stage III non-small cell lung cancer
  • Body Weight Changes
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms
  • Malnutrition

Name

Location

Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center Cleveland, Ohio  44106-5065