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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 75 Years
Gender	All

More Inclusion & Exclusion 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 Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT03803787
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 2
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Instituto Nacional de Cancerologia de Mexico
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Oscar Arrieta, MD MSc
Principal Investigator Affiliation	Instituto Nacional de Cancerologia, Mexico
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	Mexico
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Radiation Pneumonitis

Additional Details

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

Arms & Interventions

Arms

Experimental: QT/RT + Budesonide

Patients are receiving chemotherapy (QT) and radiotherapy (RT) plus inhaled Budesonide 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.

No Intervention: QT/RT + No medication

Patients are receiving chemotherapy (QT) and radiotherapy (RT) without intervention therapy and followed during 12 months.

Experimental: Target drug/RT + Budesonide

Patients are receiving target therapy and radiotherapy (RT) plus inhaled Budesonide 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.

No Intervention: Target drug/RT + No medication

Patients are receiving target treatment and radiotherapy (RT) without intervention therapy and followed during 12 months.

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.