Clinical trial NCT00530205: Effects of Radiation Therapy on the Body in Patients With Stage III Non-Small Cell Lung Cancer
Official title: An Observation of the Change in Percent Lean Body Mass of Stage III Non-Small Cell Lung Cancer Undergoing Radiation Treatment
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Lung Cancer
Malnutrition
Weight Changes
Keywords: weight changes
malnutrition
stage III non-small cell lung cancer
Lead sponsor: Case Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2007-09-17
Enrollment: 0
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Primary care 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.

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 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

Primary outcomes:
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
measure: Comparison of energy and protein by mouth intake from baseline to treatment end
measure: Comparison of diet quality as measured by Healthy Eating Index (HEI) score from baseline to treatment end
measure: Lean body mass versus fat mass using a bioelectrical impedance analysis machine
measure: Comparison of body fat to lean body mass percentage at baseline and at treatment end
measure: Correlation of energy and protein consumption with lean body mass at baseline and treatment end
measure: Change in appetite throughout radiotherapy determined by interview at baseline and end of treatment
measure: Change in performance level (Karnofsky percentage) associated with the radiotherapy procedure determined by questions asked at baseline and end of treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
name: Jessica Stauffer, BS
role: STUDY_CHAIR
References: