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

Instituto Nacional de Cancerologia de Mexico

Status and phase: Enrolling; Phase 2

Conditions: Radiation Pneumonitis

Treatments: Drug: Inhaled budesonide

Study type: Interventional

Funder types: Other

Identifiers

NCT03803787

CI/910/17

Details and patient eligibility

About

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.

Full 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

Enrollment: 72 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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 design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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72 participants in 4 patient groups

QT/RT + Budesonide

Experimental group

Description:

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.

Treatment:

Drug: Inhaled budesonide

QT/RT + No medication

No Intervention group

Description:

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

Target drug/RT + Budesonide

Experimental group

Description:

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.

Treatment:

Drug: Inhaled budesonide

Target drug/RT + No medication

No Intervention group

Description:

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