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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:
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
  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

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:
Lung Neoplasms
Fibrosis
Pneumonia
Radiation Pneumonitis
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 26, 2016