Mitigation of Radiation Pneumonitis and Fibrosis
This study is currently recruiting participants.
(see Contacts and Locations)
Verified September 2016 by VA Office of Research and Development
Sponsor:
VA Office of Research and Development
Information provided by (Responsible Party):
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT01754909
First received: November 29, 2012
Last updated: September 14, 2016
Last verified: September 2016
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Lung Cancer Radiation Pneumonitis |
Drug: Enalapril Drug: placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver) Primary Purpose: Prevention |
| Official Title: | Mitigation of Radiation Pneumonitis and Fibrosis |
Resource links provided by NLM:
Further study details as provided by VA Office of Research and Development:
Primary Outcome Measures:
- Radiation pneumonitis [ Time Frame: one year ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]The occurrence and grade of radiation pneumonitis by radiographic criteria, using CT scanning
- Radiation fibrosis [ Time Frame: one year ] [ Designated as safety issue: No ]The occurrence and grade of radiation fibrosis by radiographic criteria, using CT scanning
- Cancer recurrence and cancer-related survival [ Time Frame: two years ] [ Designated as safety issue: Yes ]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.
| Estimated Enrollment: | 200 |
| Study Start Date: | November 2013 |
| Estimated Study Completion Date: | January 2020 |
| Estimated Primary Completion Date: | January 2020 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 35 Years to 85 Years (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Men and women undergoing radiation therapy to the chest for cancer at the Baltimore and the Milwaukee 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.
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01754909
Please refer to this study by its ClinicalTrials.gov identifier: NCT01754909
Contacts
| Contact: Eric P Cohen, MD | (410) 605-7182 | Eric.Cohen@va.gov | |
| Contact: Joseph E Berman, PT MHS | (414) 384-2000 ext 42408 | joe.berman@va.gov |
Locations
| United States, Maryland | |
| Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD | Recruiting |
| Baltimore, Maryland, United States, 21201 | |
| Contact: Eric P Cohen, MD (410) 605-7182 Eric.Cohen@va.gov | |
| Principal Investigator: Eric Phin Cohen, MD | |
| United States, Wisconsin | |
| Clement J. Zablocki VA Medical Center, Milwaukee, WI | Recruiting |
| Milwaukee, Wisconsin, United States, 53295-1000 | |
| Contact: Joseph Berman, PT 414-384-2000 ext 42408 joe.berman@va.gov | |
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 |
More Information
| Responsible Party: | VA Office of Research and Development |
| ClinicalTrials.gov Identifier: | NCT01754909 History of Changes |
| Other Study ID Numbers: | CLIN-004-12S 1I01CX000569-01A2 |
| Study First Received: | November 29, 2012 |
| Last Updated: | September 14, 2016 |
| Health Authority: | United States: Federal Government |
| Individual Participant Data | |
| Plan to Share IPD: | 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 Neoplasms Fibrosis Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Pathologic Processes 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 |
ClinicalTrials.gov processed this record on September 30, 2016