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Effects of Radiation Therapy on the Body in Patients With Stage III Non-Small Cell Lung Cancer

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ClinicalTrials.gov Identifier: NCT00530205
Recruitment Status : Withdrawn
First Posted : September 17, 2007
Last Update Posted : July 14, 2011
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
Case Comprehensive Cancer Center

Brief Summary:

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 or disease Intervention/treatment
Lung Cancer Malnutrition Weight Changes Other: physiologic testing Other: questionnaire administration Procedure: management of therapy complications Radiation: radiation therapy

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.


Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: An Observation of the Change in Percent Lean Body Mass of Stage III Non-Small Cell Lung Cancer Undergoing Radiation Treatment
Study Start Date : February 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. 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
  2. Comparison of energy and protein by mouth intake from baseline to treatment end
  3. Comparison of diet quality as measured by Healthy Eating Index (HEI) score from baseline to treatment end
  4. Lean body mass versus fat mass using a bioelectrical impedance analysis machine
  5. Comparison of body fat to lean body mass percentage at baseline and at treatment end
  6. Correlation of energy and protein consumption with lean body mass at baseline and treatment end
  7. Change in appetite throughout radiotherapy determined by interview at baseline and end of treatment
  8. Change in performance level (Karnofsky percentage) associated with the radiotherapy procedure determined by questions asked at baseline and end of treatment


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Ages Eligible for Study:   50 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Primary care center
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00530205


Locations
United States, Ohio
Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44106-5065
Sponsors and Collaborators
Case Comprehensive Cancer Center
National Cancer Institute (NCI)
Investigators
Study Chair: Jessica Stauffer, BS Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center

Additional Information:
Responsible Party: Jessica Stauffer, Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00530205     History of Changes
Other Study ID Numbers: CASE5506
P30CA043703 ( U.S. NIH Grant/Contract )
CASE5506 ( Other Identifier: Case Comprehensive Cancer Center )
CASE-5506-CC217
First Posted: September 17, 2007    Key Record Dates
Last Update Posted: July 14, 2011
Last Verified: July 2011

Keywords provided by Case Comprehensive Cancer Center:
weight changes
malnutrition
stage III non-small cell lung cancer

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Malnutrition
Body Weight Changes
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Nutrition Disorders
Body Weight
Signs and Symptoms