Using inhaled steroids to prevent radiation pneumonitis in lung cancer patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: ogarrieta@gmail.com
• Phone: 015556280400

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.