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

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00530205
• Other study ID #: CASE5506
• Secondary ID: P30CA043703CASE5
• Status: Withdrawn
• Phase: N/A
• First received: September 13, 2007
• Last updated: July 13, 2011
• Start date: February 2007

Study information

• Verified date: July 2011
• Source: Case Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 75 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Body Weight Changes
• Carcinoma, Non-Small-Cell Lung
• Lung Cancer
• Lung Neoplasms
• Malnutrition
• Weight Changes

Intervention

Other:
• physiologic testing

• questionnaire administration

Procedure:
• management of therapy complications

Radiation:
• radiation therapy

Locations

Country	Name	City	State
United States	Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center	Cleveland	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Case Comprehensive Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Comparison of energy and protein by mouth intake from baseline to treatment end
Primary	Comparison of diet quality as measured by Healthy Eating Index (HEI) score from baseline to treatment end
Primary	Lean body mass versus fat mass using a bioelectrical impedance analysis machine
Primary	Comparison of body fat to lean body mass percentage at baseline and at treatment end
Primary	Correlation of energy and protein consumption with lean body mass at baseline and treatment end
Primary	Change in appetite throughout radiotherapy determined by interview at baseline and end of treatment
Primary	Change in performance level (Karnofsky percentage) associated with the radiotherapy procedure determined by questions asked at baseline and end of treatment

External Links

•   Clinical trial summary from the National Cancer Institute's PDQ® database