An Observation of the Change in Percent Lean Body Mass of Stage III Non-Small Cell Lung Cancer Undergoing Radiation Treatment
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- 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
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 50 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
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
次要结局
未报告次要终点