Clinical Trial: Mitigation of Radiation Pneumonitis and Fibrosis

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Mitigation of Radiation Pneumonitis and Fibrosis

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.

Detailed Summary:

Aim 1: To test the benefit of enalapril, an angiotensin-converting-enzyme-inhibitor, to mitigate radiation pneumonitis and fibrosis in humans.

Subjects

Men and women undergoing radiation therapy for lung cancer or other intrathoracic cancers at the Baltimore the Milwaukee or Ann Arbor Veterans Affairs Hospital are eligible. Subjects will be recruited to this phase 2 trial after their diagnosis of cancer and after referral to Radiation Oncology for treatment. The existence of this study will be posted in the Radiation Oncology clinics. Dr Cohen, Dr Beth Gore, and Dr Michelle Mierzwa (co-investigators) and our study coordinators will ensure recruitment. The informed consent process will be done by Dr Cohen or Gore or Dr Mierzwa or the study coordinators. Subjects who require radiation therapy to attempt to cure or to palliate their disease will be eligible for this study. 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. Use of other antihypertensives is not an exclusion criterion. There will be no inclusion or exclusion by race or ethnic origin. Women and minorities are eligible. Children are not eligible because children do not develop lung cancer. Previous surgery and past or current use of chemotherapy are not exclusions. Subjects will have a Karnofsky performance status >/=70, absolute neutrophils > 1000/mm^3, platelets > 75,000/mm^3, and hematocrit > 25%. Liver and kidney function tests will be within normal range and baseline blood pressure will be systolic > 110 mmHg sitting. Pregnant or nursing subjects are excluded and fertile patients will use contraception. Lung function tests including spirometry, lung volumes and diffusing capacity will be obta
Sponsor: VA Office of Research and Development

Current Primary Outcome: 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)


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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.


Original Secondary Outcome: Same as current

Information By: VA Office of Research and Development

Dates:
Date Received: November 29, 2012
Date Started: November 1, 2013
Date Completion: January 2020
Last Updated: February 21, 2017
Last Verified: February 2017