Inhaled budesonide
DrugPatients 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.
Other names: Numark
NCT Number: NCT03803787
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.
Interested in participating?
Request Info18 year–75 year
All sexes
Interventional
Phase 2
Instituto Nacional de Cancerologia, Mexico City, 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
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Other names: Numark
Time frame: from the beginning of radiotherapy up to 1 year after the 1st session.
Current score for radiation pneumonitis according to symptoms and radiographic changes. Grade 0: No changes, Grade 1: Asymptomatic or mild respiratory symptoms, Grade 2: Moderate respiratory symptoms of pneumonitis (a severe cough) and radiographic changes (radiographic patches), Grade 3: Severe respiratory symptoms of pneumonitis, dense radiographic changes. Grade 4: Symptoms of acute respiratory failure requiring assisted ventilation or continuous oxygen. Grade 5: Death directly related to late effects of radiotherapy.
Time frame: from the beginning of radiotherapy up to 1 year after the 1st session.
Current score for radiation pneumonitis according to symptoms and radiographic changes. Grade 0: No changes, Grade 1: Asymptomatic, only radiological or tomographic findings, Grade 2: Symptomatic, does not interfere with daily activities, Grade 3: Symptomatic, interferes with daily activities, requires supplemental oxygen. Grade 4: Threatens life, needing ventilator support. Grade 5: Severe pneumonitis with fatal outcome.
Time frame: before the start of Radiotherapy, and at 6, 12, 24 and 48-weeks post-treatment.
Symptoms are evaluated with the supplementary lung cancer-specific questionnaire of the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (validated Mexican-Spanish version).
It comprises 13 questions related to the assessment of dyspnoea, pain, coughing, sore mouth, dysphagia, peripheral neuropathy, alopecia, and hemoptysis. The items scale ranges from 1 (Not at all) to 4 (Very much). The average of the items that contribute to the scale (raw score) is estimated and transformed so that scores range from 0 to 100. A higher scale score represents a higher level of symptoms.
Time frame: before the start of Radiotherapy, and at 6, 12, 24 and 48-weeks post-treatment.
Symptoms are evaluated with the supplementary lung cancer-specific questionnaire of the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (validated Mexican-Spanish version).
It comprises 13 questions related to the assessment of dyspnoea, pain, coughing, sore mouth, dysphagia, peripheral neuropathy, alopecia, and hemoptysis. The items scale ranges from 1 (Not at all) to 4 (Very much). The average of the items that contribute to the scale (raw score) is estimated and transformed so that scores range from 0 to 100. A higher scale score represents a higher level of side-effects.
Time frame: before the start of Radiotherapy, and at 6, 12, 24 and 48-weeks post-treatment.
The cognitive functioning is evaluated using the validated Mexican-Spanish version of the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaires.
It comprises two questions related to the assessment of short and long-term memory. The items scale ranges from 1 (Not at all) to 4 (Very much). The average of the items that contribute to the scale (raw score) is estimated and transformed so that scores range from 0 to 100. A higher scale score represents a healthy level of functioning.
Time frame: before the start Radiotherapy, and at 6, 12, 24 and 48-weeks post-treatment
The Emotional Functioning is evaluated using the validated Mexican-Spanish version of the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaires.
It comprises four questions related to the assessment of depression, anxiety, irritability, and stress. The items scale ranges from 1 (Not at all) to 4 (Very much). The average of the items that contribute to the scale (raw score) is estimated and transformed so that the scores range from 0 to 100. A higher scale score represents a represents a healthy level of functioning.
Time frame: before the start Radiotherapy, and at 6, 12, 24 and 48-weeks post-treatment.
The Physical functioning is evaluated using the validated Mexican-Spanish version of the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaires.
It comprises five questions related to self-sufficiency activities (eating, walking, laying in bed or completing simple chores). The items scale ranges from 1 (Not at all) to 4 (Very much). The average of the items that contribute to the scale (raw score) is estimated and transformed so that the scores range from 0 to 100. A higher scale score represents a represents a healthy level of functioning.
Time frame: before the start Radiotherapy, and at 6, 12, 24 and 48-weeks post-treatment.
The Role functioning is evaluated using the validated Mexican-Spanish version of the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaires.
It comprises two questions related to daily activities (work and hobbies limitation). The items scale ranges from 1 (Not at all) to 4 (Very much). The average of the items that contribute to the scale (raw score) is estimated and transformed so that the scores range from 0 to 100. A higher scale score represents a represents a healthy level of functioning.
Time frame: before the start Radiotherapy, and at 6, 12, 24 and 48-weeks post-treatment.
The Social Functioning is evaluated using the validated Mexican-Spanish version of the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaires.
It comprises two questions related to family life and social activities. The items scale ranges from 1 (Not at all) to 4 (Very much). The average of the items that contribute to the scale (raw score) is estimated and transformed so that the scores range from 0 to 100. A higher scale score represents a represents a healthy level of functioning.
Time frame: before the start Radiotherapy, and at 6, 12, 24 and 48-weeks post-treatment.
Respiratory symptoms are evaluated using the St. George respiratory questionnaire validated to Mexican-Spanish version. It is a disease-specific instrument designed to measure the impact on overall health, daily life, and perceived well-being in patients with airways disease. Scores range from 0 to 100, with higher scores indicating more limitations.
Time frame: before the start Radiotherapy, and at 6, 12, 24 and 48-weeks post-treatment.
A system used to document the severity of the patient's shortness of breath using numbers anchored with verbal descriptions. This scale asks the patient to rate the dyspnea. It starts at number 0 where the breathing is causing no difficulty at all and progresses through to number 10 where the breathing difficulty is maximal.
Time frame: before the start of Radiotherapy, and at 6, 12, 24 and 48-weeks post-treatment
Spirometry measures the inhaled and exhaled air volume as a function of time using a forced expiratory maneuver.
Time frame: before the start of Radiotherapy and at 6, 12, 24 and 48-weeks post-treatment.
Diffusion lung capacity of carbon monoxide (DLCO) test measures the conductance of gas transfer from inspired gas to the red blood cells.
Time frame: before the start of Radiotherapy, and at 6, 12, 24 and 48-weeks post-treatment.
Nitric oxide concentration detected in the exhaled gas by chemiluminescence reported as particles per million.
Time frame: before the start of Radiotherapy, and at 6, 12, 24 and 48-weeks post-treatment.
Impulse oscillometry provides a rapid, noninvasive measure of airway impedance during normal tidal breathing.
Contact information is provided by the study sponsor or research team.
Instituto Nacional de Cancerologia de Mexico
Other
Prophylactic Inhaled Steroids to Reduce Radiation Pneumonitis Frequency and Severity in Non-small Cell Lung Cancer Patients
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