Mitigation of Radiation Pneumonitis and Fibrosis
Completed · Phase 2 · Has a placebo group
Conditions studied: Lung Cancer, Radiation Pneumonitis
In brief
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.
Key facts
- Study ID
- NCT01754909
- Run by
- VA Office of Research and Development
- People needed
- 50
- Starts
- 2013-11-01
- Expected to finish
- 2018-04-01
- Last updated by the study team
- 2019-10-08
Who can join
Age: 35 and older, up to 85. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD — Baltimore, Maryland, United States
- VA Ann Arbor Healthcare System, Ann Arbor, MI — Ann Arbor, Michigan, United States
- Clement J. Zablocki VA Medical Center, Milwaukee, WI — Milwaukee, Wisconsin, United States
Full record on ClinicalTrials.gov
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