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CompletedPhase 2NCT01754909
Official study title

Mitigation of Radiation Pneumonitis and Fibrosis

Study 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.

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Key things to know

Main goalPrevention

This describes the study’s primary purpose.

What is being studiedEnalapril and placebo

The study team can explain what participation involves.

Who it may be forLung Cancer · Radiation Pneumonitis

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Oct 8, 2019 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 2

Interventional

Where is it offered?3 U.S. locations

Locations may change over time.

Who runs it?VA Office of Research and Development

Study sponsor

01
Study overview

What this study is about

Purpose
Prevention
Study type
Interventional
Phase
Phase 2
Sponsor
VA Office of Research and Development
Interventions being studied
Drug: Enalapril; Drug: placebo
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Treatment approach
Radiation therapy→
Study topics
Survivorship and quality of life→
03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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.
Reasons someone may not be able to joinExclusion 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.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MDBaltimore, Maryland
  • VA Ann Arbor Healthcare System, Ann Arbor, MIAnn Arbor, Michigan
  • Clement J. Zablocki VA Medical Center, Milwaukee, WIMilwaukee, Wisconsin

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Oct 8, 2019. Always confirm current availability with the study team.

View original record ↗