Mitigation of Radiation Pneumonitis and Fibrosis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 3
- 主要终点
- Number of Participants With Radiation Pneumonitis
研究概览
简要总结
This project will test the effect of enalapril to mitigate the lung damage that can occur as a side effect of radiation therapy for lung cancer or other intrathoracic cancers. Thousands of Veterans develop lung cancer every year, and are treated by radiation therapy. Studies of lung radiation injury in laboratory animals show that with enalapril, investigators can significantly reduce the severity of radiation injury to the lung. Enalapril is FDA approved and in common use for treatment of hypertension, kidney disease, and heart failure. These studies will advance that work to human use. Successful mitigation of lung radiation damage will improve the quality of life in Veterans and non-Veterans who are treated for lung cancer by radiation, and may also improve cure rates of radiation therapy for lung cancer.
详细描述
Aim 1: To test the benefit of enalapril, an angiotensin-converting-enzyme-inhibitor, to mitigate radiation pneumonitis and fibrosis in humans.
Subjects
Men and women undergoing radiation therapy for lung cancer or other intrathoracic cancers at the Baltimore the Milwaukee or Ann Arbor Veterans Affairs Hospital are eligible. Subjects will be recruited to this phase 2 trial after their diagnosis of cancer and after referral to Radiation Oncology for treatment. The existence of this study will be posted in the Radiation Oncology clinics. Dr Cohen, Dr Beth Gore, and Dr Michelle Mierzwa (co-investigators) and our study coordinators will ensure recruitment. The informed consent process will be done by Dr Cohen or Gore or Dr Mierzwa or the study coordinators. Subjects who require radiation therapy to attempt to cure or to palliate their disease will be eligible for this study. Subjects eligible for surgical resection and who do not need radiation therapy will not be eligible for this study. Subjects on ACE inhibitors, angiotensin blockers, or renin antagonists will be excluded. Use of other antihypertensives is not an exclusion criterion. There will be no inclusion or exclusion by race or ethnic origin. Women and minorities are eligible. Children are not eligible because children do not develop lung cancer. Previous surgery and past or current use of chemotherapy are not exclusions. Subjects will have a Karnofsky performance status >/=70, absolute neutrophils > 1000/mm^3, platelets > 75,000/mm^3, and hematocrit > 25%. Liver and kidney function tests will be within normal range and baseline blood pressure will be systolic > 110 mmHg sitting. Pregnant or nursing subjects are excluded and fertile patients will use contraception. Lung function tests including spirometry, lung volumes and diffusing capacity will be obtained as part of standard of care for patients prior to radiotherapy, but indices from lung function tests will not be a cause for exclusion.
The mean lung dose will be >/= 18 Gy and/or V20 >20%. Radiation will be delivered with standard fractionation schedule of 1.8 to 2 Gy per day, 5 days per week, without planned treatment breaks.
Experimental design
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 35 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women undergoing radiation therapy to the chest for cancer at the Baltimore, the Milwaukee, and Ann Arbor Veterans Affairs Hospital are eligible.
- •Subjects who require radiation therapy to attempt to cure or to palliate their disease will be eligible for this study.
排除标准
- •Subjects eligible for surgical resection and who do not need radiation therapy will not be eligible for this study.
- •Subjects who must remain on ACE inhibitors, angiotensin blockers, or renin antagonists will be excluded.
研究组 & 干预措施
enalapril
Use of enalapril in subjects undergoing radiotherapy for lung cancer.
干预措施: Enalapril (Drug)
placebo
Use of placebo in subjects undergoing radiotherapy for lung cancer
干预措施: placebo (Drug)
结局指标
主要结局
Number of Participants With Radiation Pneumonitis
时间窗: two years
The clinical occurrence and grade of radiation pneumonitis, by National Cancer Institute Common Terminology Criteria Adverse Event grading ( NCI CTCAE)
次要结局
- Number of Participants With Radiation Pneumonitis by CT Scan(six months)
- Number of Participants With Radiation Fibrosis(one year)