Clinical Trial: Mitigation of Radiation Pneumonitis, Fibrosis and Heart Toxicity With Nicorandil in Lung Cancer Patients

Study Status: Enrolling by invitation
Recruit Status: Enrolling by invitation
Study Type: Interventional

Official Title: Mitigation of Radiation Pneumonitis, Fibrosis and Heart Toxicity With Nicorandil in Lung Cancer Patients

Brief Summary: 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.

Detailed Summary:
Sponsor: Taipei Medical University WanFang Hospital

Current Primary Outcome: 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 ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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 ]


Original Secondary Outcome:

  • 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 ]
  • To compare radiation pneumonitis (RP) score in patients who received nicorandil versus observation [ Time Frame: Baseline up to 2.5 years post-treatment ]
  • To compare 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 nintedanib versus observation. [ Time Frame: Baseline up to 2.5 years post-treatment ]
  • Responses rates [ Time Frame: Up to 2.5 years post-treatment ]


Information By: Taipei Medical University WanFang Hospital

Dates:
Date Received: June 9, 2016
Date Started: July 2016
Date Completion: December 2019
Last Updated: June 22, 2016
Last Verified: June 2016