Phase 2
N=43
Mitigation of Radiation Pneumonitis and Fibrosis
Lung Cancer · Radiation Pneumonitis
Bottom Line
View on ClinicalTrials.gov: NCT01754909 ↗Enrolled (actual)
43
Serious AEs
46.5%
Results posted
Oct 2019
Primary outcome: Primary: Number of Participants With Radiation Pneumonitis — 8; 10 participants — p=0.05
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Enalapril (Drug); placebo (Drug)
- Age
- Adult, Older Adult · 35+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Apr 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Radiation Pneumonitis |
8; 10 | 0.05 |
| SECONDARY Number of Participants With Radiation Pneumonitis by CT Scan |
16; 12 | — |
| SECONDARY Number of Participants With Radiation Fibrosis |
8; 4 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT01754909). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.