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Mitigation of Radiation Pneumonitis and Fibrosis

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ClinicalTrials.gov Identifier: NCT01754909
Recruitment Status : Active, not recruiting
First Posted : December 21, 2012
Last Update Posted : January 9, 2018
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Brief 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.

Condition or disease Intervention/treatment Phase
Lung Cancer Radiation Pneumonitis Drug: Enalapril Drug: placebo Phase 2

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Prevention
Official Title: Mitigation of Radiation Pneumonitis and Fibrosis
Actual Study Start Date : November 1, 2013
Estimated Primary Completion Date : January 31, 2020
Estimated Study Completion Date : January 31, 2020

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: enalapril
Use of enalapril in subjects undergoing radiotherapy for lung cancer.
Drug: Enalapril
Enalapril once a day, orally, as 2.5 , 5, or 10 mg tablets to be given in escalating doses, to subjects undergoing radiotherapy for lung cancer
Placebo Comparator: placebo
Use of placebo in subjects undergoing radiotherapy for lung cancer
Drug: placebo
Placebo, once a day, orally, as 2.5 , 5, or 10 mg tablets to be given in escalating doses, to subjects undergoing radiotherapy for lung cancer



Primary Outcome Measures :
  1. Radiation pneumonitis [ Time Frame: one year ]
    The clinical occurrence and grade of radiation pneumonitis, by National Cancer Institute Common Terminology Criteria Adverse Event grading ( NCI CTCAE)


Secondary Outcome Measures :
  1. Radiation pneumonitis [ Time Frame: one year ]
    The occurrence and grade of radiation pneumonitis by radiographic criteria, using CT scanning

  2. Radiation fibrosis [ Time Frame: one year ]
    The occurrence and grade of radiation fibrosis by radiographic criteria, using CT scanning

  3. Cancer recurrence and cancer-related survival [ Time Frame: two years ]
    The recurrence of lung cancer after radiation therapy and the cancer-related survival after radiation therapy, in subjects taking enalapril compared to those on placebo drug.



Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01754909


Locations
United States, Maryland
Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
Baltimore, Maryland, United States, 21201
United States, Michigan
VA Ann Arbor Healthcare System, Ann Arbor, MI
Ann Arbor, Michigan, United States, 48105
United States, Wisconsin
Clement J. Zablocki VA Medical Center, Milwaukee, WI
Milwaukee, Wisconsin, United States, 53295-1000
Sponsors and Collaborators
VA Office of Research and Development
Investigators
Principal Investigator: Eric Phin Cohen, MD Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD

Publications:
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT01754909     History of Changes
Other Study ID Numbers: CLIN-004-12S
1I01CX000569-01A2 ( U.S. NIH Grant/Contract )
First Posted: December 21, 2012    Key Record Dates
Last Update Posted: January 9, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by VA Office of Research and Development:
lung cancer
radiation pneumonitis
mitigation
enalapril
placebo

Additional relevant MeSH terms:
Pneumonia
Radiation Pneumonitis
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Lung Diseases, Interstitial
Lung Injury
Radiation Injuries
Wounds and Injuries
Enalapril
Enalaprilat
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antihypertensive Agents