RecruitingPhase 2NCT03803787

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

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

Sponsor

Instituto Nacional de Cancerologia de Mexico

Enrollment

72 participants

Start Date

Sep 1, 2018

Study Type

INTERVENTIONAL

Conditions

Radiation Pneumonitis

Summary

This randomized clinical study aims to assess whether prophylactic treatment with inhaled steroids in patients with locally advanced or concomitantly treated non-small cell lung carcinoma who are candidates for combination treatment with QT/RT or IMT + QT/RT. The main questions it aims to answer are: Whether prophylactic treatment decreases the severity of NPR on CTCAE v4.0 and RTOG scales. Whether inhaled steroid use modifies the response to radiation therapy treatment compared to patients who do not receive prophylactic inhaled steroids.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing whether using an inhaled steroid spray (like an asthma inhaler) during radiation treatment can prevent or reduce lung inflammation — a common and painful side effect of radiation therapy for lung cancer. **You may be eligible if...** - You have non-small cell lung cancer (NSCLC) that cannot be removed with surgery - You are scheduled to receive both chemotherapy and radiation at the same time, or targeted therapy and radiation - You are generally well enough to carry out daily activities (not bedridden) - You have a life expectancy of more than 4 months - You are willing and able to follow the study procedures **You may NOT be eligible if...** - Your cancer has a different type or stage - You are not able to commit to the study schedule - You had surgery less than 4 weeks ago Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGInhaled budesonide

Patients will use inhaled budesonide (Numark) with space chamber at 400 mcg given twice daily initiating after the first dose of RT and continuing until pneumonitis development or 12 months completed.