Effects of Radiation Therapy on the Body in Patients With Stage III Non-Small Cell Lung Cancer
NCT ID: NCT00530205
Last Updated: 2011-07-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
OBSERVATIONAL
2007-02-28
Brief Summary
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PURPOSE: This clinical trial is studying the effects of radiation therapy on the body in patients with stage III non-small cell lung cancer.
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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physiologic testing
questionnaire administration
management of therapy complications
radiation therapy
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Native language other than American English
* Pacemaker or implanted defibrillator
PRIOR CONCURRENT THERAPY:
* Receiving chemotherapy in combination with radiotherapy
* Concurrent megace or steroids
50 Years
75 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Case Comprehensive Cancer Center
OTHER
Responsible Party
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Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
Principal Investigators
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Jessica Stauffer, BS
Role: STUDY_CHAIR
Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
Locations
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Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
Cleveland, Ohio, United States
Countries
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Related Links
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Clinical trial summary from the National Cancer Institute's PDQ® database
Other Identifiers
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CASE5506
Identifier Type: OTHER
Identifier Source: secondary_id
CASE-5506-CC217
Identifier Type: -
Identifier Source: secondary_id
CASE5506
Identifier Type: -
Identifier Source: org_study_id
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