Prophylactic Inhaled Steroids to Reduce Radiation Pneumonitis Frequency and Severity in Lung Cancer Patients
Recruiting · NCT03803787 · Interventional (participants receive a specific treatment) · Lead sponsor: Instituto Nacional de Cancerologia de Mexico
View the official record on ClinicalTrials.gov →Interventions studied
Inhaled budesonide
What this trial is about
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.
Who can take part
Age range
18 Years to 75 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
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 is running
2 locations listed.
- Instituto Nacional de Cancerologia - Mexico City, Mexico
- Instituto Nacional de Enfermedades Respiratorias - Mexico City, Mexico