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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.
First Received: September 13, 2007   Last Updated: February 6, 2009   History of Changes
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
Other: physiologic testing
Other: questionnaire administration
Procedure: management of therapy complications
Radiation: radiation therapy

MedlinePlus related topics: Cancer Diets Lung Cancer Radiation Therapy
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

Additional Information:
No publications provided

Study ID Numbers: CDR0000564247, CASE-5506, CASE-5506-CC217
Study First Received: September 13, 2007
Last Updated: February 6, 2009
ClinicalTrials.gov Identifier: NCT00530205     History of Changes
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
Malnutrition
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases
Body Weight Changes
Non-small Cell Lung Cancer
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:
Thoracic Neoplasms
Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Carcinoma

ClinicalTrials.gov processed this record on May 07, 2009