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

• Status: Recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Thoracic lung cancer treatment often induces lung toxicity as an adverse effect of concomitant therapy (CCRT) using chemo or target therapy drugs in addition to radiation therapy, in non-small cell lung cancer (NSCLC) patients with advanced disease. The presence of Pneumonitis is the most severe acute lung injury derived from this intervention. Pneumonitis might evolve to respiratory failure and even death, with a high incidence in the investigator's population (50%) as reported in different studies. Its prevention with different immunomodulatory targets has not succeeded. The use of inhaled steroids is used in various pathologies such as Asthma and Chronic Obstructive Pulmonary Disease (COPD) to reduce the airway inflammatory response. The advantage of using inhaled corticosteroids as opposed to orally administered drugs bases in the low incidence of systemic side effects and the fact that its use does not require tapering. Currently, the effectiveness of using prophylactic inhaled steroids for reducing the incidence of CCRT-induced pneumonitis and its impact regarding the quality of life has not been demonstrated in a clinical trial.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Instituto Nacional de Cancerologia de Mexico
• Collaborator: Instituto Nacional de Enfermedades Respiratorias
• Treatments: Budesonide

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