Mitigation of Radiation Pneumonitis and Fibrosis

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 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: July 22, 2014
Last verified: July 2014
  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: 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
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 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 (414) 384-2000 ext 42825 Eric.Cohen@va.gov

Locations
United States, Wisconsin
Clement J. Zablocki VA Medical Center, Milwaukee, WI Recruiting
Milwaukee, Wisconsin, United States, 53295-1000
Contact: Joseph E Berman, PT MHS    414-384-2000 ext 42408    joe.berman@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: July 22, 2014
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 August 20, 2014