Mitigation of Radiation Pneumonitis and Fibrosis
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT01754909 |
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Recruitment Status :
Completed
First Posted : December 21, 2012
Last Update Posted : June 6, 2018
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Sponsor:
VA Office of Research and Development
Information provided by (Responsible Party):
VA Office of Research and Development
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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) |
| Actual Enrollment : | 50 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 |
| Actual Primary Completion Date : | April 1, 2018 |
| Actual Study Completion Date : | April 1, 2018 |
Resource links provided by the National Library of Medicine
Genetics Home Reference related topics:
Lung cancer
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: enalapril
Use of enalapril in subjects undergoing radiotherapy for lung cancer.
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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 |
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Placebo Comparator: placebo
Use of placebo in subjects undergoing radiotherapy for lung cancer
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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 :
- 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 :
- Radiation pneumonitis [ Time Frame: one year ]The occurrence and grade of radiation pneumonitis by radiographic criteria, using CT scanning
- Radiation fibrosis [ Time Frame: one year ]The occurrence and grade of radiation fibrosis by radiographic criteria, using CT scanning
- 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.
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| Ages Eligible for Study: | 35 Years to 85 Years (Adult, Older Adult) |
| 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 of Results:
| 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: | June 6, 2018 |
| Last Verified: | June 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:
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lung cancer radiation pneumonitis mitigation enalapril placebo |
Additional relevant MeSH terms:
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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 |