Prophylactic Inhaled Steroids to Reduce Radiation Pneumonitis Frequency and Severity in Non-small Cell Lung Cancer Patients

What this Trial Is About

Researchers are evaluating whether using inhaled steroids before radiation therapy can reduce the frequency and severity of radiation pneumonitis in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who are receiving chemotherapy plus radiotherapy or targeted therapy plus radiotherapy. The study focuses on whether inhaled steroids affect lung inflammation and change the response to radiation treatment. This is a randomized Phase 2 clinical trial sponsored by Instituto Nacional de Cancerologia de Mexico. Participants are assigned to receive either inhaled budesonide at 400 mcg twice daily with a spacer chamber or no additional medication, alongside their standard chemotherapy or targeted therapy combined with radiotherapy. Treatment with budesonide starts after the first radiation session and continues until pneumonitis occurs or up to 12 months. Devices containing the medication are provided monthly, and patients keep a log of their inhaler use to track adherence. During the study, participants undergo baseline assessments including medical history, lung function tests, and multiple quality of life and respiratory symptom questionnaires. Blood samples are collected before radiation and every six weeks for up to 48 weeks to measure inflammation markers. Follow-up evaluations of lung function, respiratory symptoms, side effects, and quality of life continue at 6, 12, 24, and 48 weeks after treatment. Pneumonitis severity is monitored for one year from the start of radiation therapy to assess the study's primary outcomes.

Prophylactic Inhaled Steroids to Reduce Radiation Pneumonitis Frequency and Severity in Lung Cancer Patients