Ignite Creation Date:
2025-12-25 @ 3:33 AM
Ignite Modification Date:
2025-12-26 @ 2:15 AM
Study NCT ID:
NCT00530205
Status:
WITHDRAWN
Last Update Posted:
2011-07-14
First Post:
2007-09-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of Radiation Therapy on the Body in Patients With Stage III Non-Small Cell Lung Cancer
Sponsor:
Case Comprehensive Cancer Center
Organization:
Study Overview
Official Title:
An Observation of the Change in Percent Lean Body Mass of Stage III Non-Small Cell Lung Cancer Undergoing Radiation Treatment
Status:
WITHDRAWN
Status Verified Date:
2011-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| P30CA043703 | NIH | None | https://reporter.nih.gov/quic… | View |
| CASE5506 | OTHER | Case Comprehensive Cancer Center | View | |
| CASE-5506-CC217 | None | None | View |