Effects of Radiation Therapy on the Body in Patients With Stage III Non-Small Cell Lung Cancer
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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 |
|---|---|
|
Lung Cancer Malnutrition Weight Changes |
Other: physiologic testing Other: questionnaire administration Procedure: management of therapy complications Radiation: radiation therapy |
| Study Type: | Observational |
| Study Design: | 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 |
- 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
| Enrollment: | 0 |
| Study Start Date: | February 2007 |
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 |
| Sampling Method: | Probability Sample |
Primary care center
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| United States, Ohio | |
| Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center | |
| Cleveland, Ohio, United States, 44106-5065 | |
| Study Chair: | Jessica Stauffer, BS | Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center |
More Information
Additional Information:
No publications provided
| 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, CASE5506, CASE-5506-CC217 |
| Study First Received: | September 13, 2007 |
| Last Updated: | July 13, 2011 |
| Health Authority: | United States: Federal Government |
Keywords provided by Case Comprehensive Cancer Center:
|
weight changes malnutrition stage III non-small cell lung cancer |
Additional relevant MeSH terms:
|
Body Weight Changes Carcinoma, Non-Small-Cell Lung Lung Neoplasms Malnutrition Body Weight Signs and Symptoms Carcinoma, Bronchogenic Bronchial Neoplasms |
Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Nutrition Disorders |
ClinicalTrials.gov processed this record on May 23, 2013