This project will test the effect of nicorandil 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 nicorandil, investigators can significantly reduce the severity of lung fibrosis and heart toxicity.1,2 Nicorandil is FDA approved and in common use for treatment of angina. These studies will advance that work to human use. Successful mitigation of lung radiation damage and heart toxicity 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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
50
oral intake
The rate of symptomatic radiation pneumonitis in patients with unresectable Stage II/III/ oligometastatic IV non-small cell lung carcinoma (NSCLC) who completed chemoradiation followed by nicorandil or not
Time frame: Up to 2.5 years post-treatment
The quality of life (QOL) questionnaire
Time frame: Baseline up to 2.5 years post-treatment
Biomarker analysis such as TGF-β, Serum surfactant proteins-A & -D, MMP1 and MMP7
Time frame: Up to 97 days post-treatment
The overall survival in patients who received nicorandil versus observation
Time frame: Up to 2.5 years post-treatment
Radiation pneumonitis (RP) score in patients who received nicorandil versus observation
Time frame: Baseline up to 2.5 years post-treatment
The composite index (based on PFT, RP score and QOL) at the end of active treatment and 6 months after completion of treatment between patients who received nicorandil versus observation.
Time frame: Baseline up to 2.5 years post-treatment
Responses rates
Time frame: Up to 2.5 years post-treatment
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