Prophylactic Inhaled Steroids to Reduce Radiation Pneumonitis Frequency and Severity in Lung Cancer Patients
72 patients around the world
Available in Mexico
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
Instituto Nacional de Cancerologia de Mexico
1Research sites
72Patients around the world
Requirements for the patient
To 75 Years
All Gender
Medical requirements
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.
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
Sites
Instituto Nacional de Cardiologia Ignacio Chavez
Recruiting
Juan Badiano 1, Belisario Domínguez Secc 16, Tlalpan, Ciudad de México
SponsorInstituto Nacional de Cancerologia de Mexico