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

An Observation of the Change in Percent Lean Body Mass of Stage III Non-Small Cell Lung Cancer Undergoing Radiation Treatment

Status
Withdrawn
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00530205
Enrollment
0
Registered
2007-09-17
Start date
2007-02-28
Completion date
Unknown
Last updated
2011-07-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Cancer, Malnutrition, Weight Changes

Keywords

weight changes, malnutrition, stage III non-small cell lung cancer

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.

Interventions

OTHERphysiologic testing
OTHERquestionnaire administration
PROCEDUREmanagement of therapy complications
RADIATIONradiation therapy

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
Case Comprehensive Cancer Center
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
50 Years to 75 Years
Healthy volunteers
No

Inclusion 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:

Design outcomes

Primary

MeasureTime frame
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026