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Effects of Radiation Therapy on the Body in Patients With Stage III Non-Small Cell Lung Cancer
This study has been completed.
Sponsors and Collaborators: Case Comprehensive Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00530205
  Purpose

RATIONALE: Learning about the effects of radiation therapy on the body's muscles, organs, and bones in patients with stage III non-small cell lung cancer may help doctors plan the best treatment.

PURPOSE: This clinical trial is studying the effects of radiation therapy on the body in patients with stage III non-small cell lung cancer.


Condition Intervention
Cancer-Related Problem/Condition
Lung Cancer
Procedure: management of therapy complications
Procedure: physiologic testing
Procedure: questionnaire administration
Procedure: radiation therapy

MedlinePlus related topics: Cancer Lung Cancer
U.S. FDA Resources
Study Type: Observational
Official Title: An Observation of the Change in Percent Lean Body Mass of Stage III Non-Small Cell Lung Cancer Undergoing Radiation Treatment

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • 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
  • Comparison of energy and protein by mouth intake from baseline to treatment end
  • Comparison of diet quality as measured by Healthy Eating Index (HEI) score from baseline to treatment end
  • Lean body mass versus fat mass using a bioelectrical impedance analysis machine
  • Comparison of body fat to lean body mass percentage at baseline and at treatment end
  • Correlation of energy and protein consumption with lean body mass at baseline and treatment end
  • Change in appetite throughout radiotherapy determined by interview at baseline and end of treatment
  • Change in performance level (Karnofsky percentage) associated with the radiotherapy procedure determined by questions asked at baseline and end of treatment

Estimated Enrollment: 45
Study Start Date: February 2007
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   50 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00530205

Locations
United States, Ohio
Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44106-5065
Sponsors and Collaborators
Case Comprehensive Cancer Center
Investigators
Study Chair: Jessica Stauffer, BS Ireland Cancer Center
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Study ID Numbers: CDR0000564247, CASE-5506, CASE-5506-CC217
Study First Received: September 13, 2007
Last Updated: December 16, 2008
ClinicalTrials.gov Identifier: NCT00530205  
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
weight changes
malnutrition
stage III non-small cell lung cancer

Study placed in the following topic categories:
Thoracic Neoplasms
Body Weight
Non-small cell lung cancer
Malnutrition
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases
Body Weight Changes
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:
Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on January 16, 2009