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

NCT00530205 | Withdrawn

• 3 other identifiers: CASE5506P30CA043703CASE-5506-CC217
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Cancer; Malnutrition; Weight Changes

Keywords

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

Outcome Measures

Primary Outcomes (8)

• 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

Interventions

physiologic testing OTHER

questionnaire administration OTHER

management of therapy complications PROCEDURE

radiation therapy RADIATION

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Primary care center

You may qualify if:

• Must be able to stand without assistance

You may not qualify if:

• Unable to comply with study requirements
• Native language other than American English
• Pacemaker or implanted defibrillator
• PRIOR CONCURRENT THERAPY:
• Receiving chemotherapy in combination with radiotherapy
• Concurrent megace or steroids

Sponsors & Collaborators

• Case Comprehensive Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center

Cleveland, Ohio, 44106-5065, United States

Location

Related Links

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

MeSH Terms

Conditions

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

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Carcinoma, Bronchogenic; Bronchial Neoplasms

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Jessica Stauffer, BS

  Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 13, 2007
• First Posted: September 17, 2007
• Study Start: February 1, 2007
• Last Updated: July 14, 2011

Record last verified: 2011-07

Locations

US (1)