Trial record 3 of 40 for:
Pneumonia | Open Studies | NIH, U.S. Fed
Mitigation of Radiation Pneumonitis and Fibrosis
This study is not yet open for participant recruitment.
Verified December 2012 by Department of Veterans Affairs
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT01754909
First received: November 29, 2012
Last updated: December 18, 2012
Last verified: December 2012
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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. 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 Department of Veterans Affairs:
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: | February 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 |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Men and women undergoing radiation therapy for lung cancer at 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 already on ACE inhibitors, angiotensin blockers, or renin antagonists will be excluded.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01754909
Contacts
| Contact: Eric P Cohen, MD | (414) 384-2000 ext 42825 | Eric.Cohen@va.gov |
Locations
| United States, Wisconsin | |
| Clement J. Zablocki VA Medical Center, Milwaukee, WI | Not yet recruiting |
| Milwaukee, Wisconsin, United States, 53295-1000 | |
| Contact: Victoria Hoeft 414-384-2000 ext 41434 Victoria.Hoeft@va.gov | |
| Principal Investigator: Eric P. Cohen, MD | |
Sponsors and Collaborators
Investigators
| Principal Investigator: | Eric P. Cohen, MD | Clement J. Zablocki VA Medical Center, Milwaukee, WI |
More Information
No publications provided
| Responsible Party: | Department of Veterans Affairs |
| ClinicalTrials.gov Identifier: | NCT01754909 History of Changes |
| Other Study ID Numbers: | CLIN-004-12S, 1I01CX000569-01A2 |
| Study First Received: | November 29, 2012 |
| Last Updated: | December 18, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by Department of Veterans Affairs:
|
lung cancer radiation pneumonitis mitigation enalapril placebo |
Additional relevant MeSH terms:
|
Pneumonia Radiation Pneumonitis Fibrosis Lung Neoplasms Pathologic Processes Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms 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 Pharmacologic Actions Antihypertensive Agents Cardiovascular Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 16, 2013