Using inhaled steroids to prevent radiation pneumonitis in lung cancer patients

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

This study is testing if inhaled steroids can help lung cancer patients avoid or lessen lung problems caused by radiation treatment.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 72 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Instituto Nacional de Cancerologia de Mexico (Academic / other)
• Drugs / interventions: chemotherapy, radiation
• Locations: 2 sites (Mexico City and 1 other locations)
• Trial ID: NCT03803787 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness of prophylactic inhaled steroids in reducing the frequency and severity of radiation pneumonitis in patients with locally advanced non-small cell lung cancer undergoing radiation therapy. Participants will be randomized to receive either inhaled budesonide or standard treatment, with assessments of lung function, quality of life, and inflammatory markers conducted throughout the study. The trial aims to determine if inhaled steroids can improve patient outcomes during and after radiation treatment.

Who should consider this trial

Good fit: Ideal candidates are patients with unresectable locally advanced or metastatic non-small cell lung cancer who are receiving concurrent chemotherapy and radiation therapy.

Not a fit: Patients with unstable systemic diseases or uncontrolled chronic lung conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce the incidence and severity of radiation pneumonitis, improving the quality of life for lung cancer patients.

How similar studies have performed: Previous studies have shown promising results with inhaled steroids in similar contexts, suggesting potential for success in this trial.

Eligibility criteria

Inclusion Criteria:

* Patients with non-small cell lung cancer (NSCLC) with unresectable locally advanced or metastatic disease (IIIA, IIIB or IV) of the classification tumor node, metastasis (TNM) of malignant lung tumors, 7th edition.
* NSCLC patients candidates for concomitant treatment (chemotherapy plus radiotherapy or target therapy plus radiotherapy).
* Evidence of measurable disease
* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2, Karnofsky 70-100.
* Life expectancy of \> 4 months at the time of screening
* Patients with the ability to comply with the study and follow-up procedures.
* Patients with previous surgery less than four weeks.
* Must be willing and able to give signed informed consent and, in the opinion of the Investigator, to comply with the protocol tests and procedures.

Exclusion Criteria:

* Unstable systemic disease: active infection, heart, liver, kidney or metabolic disease; including uncontrolled chronic lung disease.
* Patients treated with systemic or inhaled corticosteroids.
* Patients of reproductive age without a family planning method, pregnant or lactating.
* Previous diagnosis of Pneumonitis with toxicity grade ≥ 2 by CTCAE v4.0 or RTOG scale.
* Patients with disease progression.
* Inspiratory flow \< 90 liters / min.
* Discontinue of Treatment

Where this trial is running

Mexico City and 1 other locations

• Instituto Nacional de Cancerologia — Mexico City, Mexico (Recruiting)
• Instituto Nacional de Enfermedades Respiratorias — Mexico City, Mexico (Active_not_recruiting)

Study contacts

• Principal investigator: Oscar Arrieta, MD MSc — Instituto Nacional de Cancerologia, Mexico
• Study coordinator: Oscar Arrieta, MD MSc

Conditions Radiation Pneumonitis; Non-Small Cell Lung Cancer; Radiation Pneumonia; Lung cancer treatment; Respiratory Tract Neoplasms; Radiation fibrosis; Thoracic Neoplasms; Lung Diseases