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

Official 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.

Study Design

• Study Type: INTERVENTIONAL
• Allocation: RANDOMIZED
• Model: PARALLEL
• Masking: NONE
• Enrollment: 72 participants

Interventions

• DRUG: Inhaled 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.

Primary Outcomes

• Pneumonitis graded by the Common terminology criteria for adverse event v4.0. (CTCAE v4.0). (from the beginning of radiotherapy up to 1 year after the 1st session.)
• Pneumonitis graded by the Radiation Therapy Oncology Group score (RTOG) (from the beginning of radiotherapy up to 1 year after the 1st session.)

Secondary Outcomes

• Lung cancer-associated symptoms assessment (before the start of Radiotherapy, and at 6, 12, 24 and 48-weeks post-treatment.)
• Treatment-related side effects in lung cancer (before the start of Radiotherapy, and at 6, 12, 24 and 48-weeks post-treatment.)
• Cognitive functioning evaluated by the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (before the start of Radiotherapy, and at 6, 12, 24 and 48-weeks post-treatment.)
• Emotional Functioning evaluated by the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (before the start Radiotherapy, and at 6, 12, 24 and 48-weeks post-treatment)
• Physical functioning evaluated by the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (before the start Radiotherapy, and at 6, 12, 24 and 48-weeks post-treatment.)

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

Trial Locations

• Instituto Nacional de Cancerologia, Mexico City, Mexico
• Instituto Nacional de Enfermedades Respiratorias, Mexico City, Mexico

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