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

This study has been withdrawn prior to enrollment.
Sponsor:
Collaborator:
Information provided by:
Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00530205
First received: September 13, 2007
Last updated: July 13, 2011
Last verified: July 2011
  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

Resource links provided by NLM:


Further study details as provided by Case Comprehensive Cancer Center:

Primary Outcome Measures:
  • 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
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

Ages Eligible for Study:   50 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Primary care center

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00530205

Locations
United States, Ohio
Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44106-5065
Sponsors and Collaborators
Case Comprehensive Cancer Center
Investigators
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
Nutrition Disorders
Body Weight
Signs and Symptoms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on August 01, 2014