NCT00165438已完成不适用
A Prospective Study of Pulmonary Function in Patients With Hodgkin's Disease Receiving Bleomycin-Based Chemotherapy With or Without Mediastinal Irradiation
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Pulmonary function
研究概览
简要总结
The purpose of this study is to find out the impact Bleomycin-containing chemotherapy, given with or without chest radiation therapy, on patients' lung function over time.
详细描述
- The tests and procedures in this study are part of regular cancer care but this study offers more structured timing of these standard tests.
- Due to the potential lung toxicity associated with bleomycin-based chemotherapy, pulmonary function tests are routinely performed. Pulmonary function tests will be performed by a licensed, registered respiratory therapist and performed prior to the beginning of treatment, between the chemotherapy and radiation therapy (only for patients receiving both chemotherapy and radiation therapy), and at approximately 1 month, 6 months, 1 year and 2 years after the completion of all treatments.
- A CAT scan will be performed prior to the beginning of treatment, and approximately 1 month, 6 months, 1 year and 2 years after the completion of all treatments.
- A self-administered questionnaire will be performed on the days the patient is undergoing pulmonary function tests.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with newly diagnosed classical Hodgkin's disease, with mediastinal involvement
- •Bleomycin-based chemotherapy alone or in combination with mediastinal irradiation
排除标准
- •Prior chest irradiation
- •Mediastinal irradiation received at an outside institution
- •Refractory or progressive disease on treatment
结局指标
主要结局
Pulmonary function
时间窗: 2 years
Changes in pulmonary function over time
次要结局
未报告次要终点
研究者
Andrea K. Ng, MD
Principal Investigator
Dana-Farber Cancer Institute
研究点 (2)
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