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Clinical Trial 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.


Clinical Trial Description

Clinical evaluation The following BASELINE data shall be taken prior to radiation therapy: Demographic, clinical, laboratory, and imaging data will be obtained from medical history and electronic records. The patient will be instructed to perform the PFRs and tests of lung function. Two EORTC, QLQ-C30, and QLQ LC13 quality of life questionnaires and three respiratory symptom questionnaires (St. George, dyspnea scale, and modified BORG) will be performed on the same day of lung function tests. Additionally; blood samples will be taken for the evaluation of inflammatory mediators at the following times: BASAL (before RT), and every six weeks up to 48 weeks post-RT. INTERVENTION GROUP 1. Prior to the onset of RT, the patient will be sorted to receive the control rather than experimental intervention (QT/RT or IMT + QT/RT) and a logbook to record adherence to treatment. 2. An IDM device shall be granted per month, containing the number of doses corresponding to 30 days. The record in the database of the day of the first session of RT will be taken to quantify the number of days of use of the drug and grant the next device per 30 days until the end of the study. 3. The patient will be instructed on the use of the device inhaled with the spacer chamber in the clinic Pulmonology consultation, alarm data and indications of the use of the drug will be given in writing, and knowledge will be reinforced at each visit. 4. The patient will be granted the drug use log where the patient will place the date and time of use of the drug to assess adherence to treatment ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03803787
Study type Interventional
Source Instituto Nacional de Cancerologia de Mexico
Contact Oscar Arrieta, MD MSc
Phone 015556280400
Email ogarrieta@gmail.com
Status Recruiting
Phase Phase 2
Start date September 1, 2018
Completion date December 1, 2024

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