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Prevention of Locally Advanced NSCLC Radiotherapy Pneumonia by Inhaling Beclomethasone Propionate | Clinical Trials | Clareo Health

UNKNOWNPHASE2

Prevention of Locally Advanced NSCLC Radiotherapy Pneumonia by Inhaling Beclomethasone Propionate

A Randomized, Open Phase II Study of the Incidence and Safety of Radiation Pneumonia in Patients With Locally Advanced NSCLC Treated With Beclomethasone Propionate Inhaled During Radical Radiotherapy Compared With Conventional Radiotherapy

NCT03886441•Tongji University

View on ClinicalTrials.gov

Summary

Radical radiotherapy is the main treatment of locally advanced lung cancer, and radiation pneumonia is the main toxic effects of radiotherapy. Among them, the fatality rate of severe radiation pneumonia can reach 50%, which is very harmful to tumor patients. At present, the treatment mode of radiation pneumonia is very few, and the therapeutic effect is poor. The prevention of radiation pneumonitis may be the best way to reduce the number of patients with Post-radiotherapy pneumonia. Previous small clinical studies have shown that the incidence of radiation pneumonia in inhaled beclomethasone group (2 /28) was significantly lower than that in oral prednisone group (8 /29) during radiotherapy. The purpose of this study was to compare the efficacy and safety of radiotherapy between the therapeutic group (inhaled beclomethasone during radiotherapy) and the control radiotherapy group (patients received radiotherapy only), especially the incidence of radiation-induced pneumonia within half a year.

Detailed Description

To compare the incidence of radiation pneumonia, effect and side effects of radiotherapy in lung between beclomethasone inhalation therapeutic group and control radiotherapy group in patients with locally advanced non-small cell lung cancer (NSCLC) during radiotherapy.

Eligibility

Age

18 - 70 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. The subjects understood the requirements and risks of the study fully and signed the informed consent form.
•2. Aged between 18 and 70 years;
•3. Histologically or cytologically confirmed diagnosis of locally advanced non-small cell lung cancer.
•4. All of these patients have pointers to radical radiation and can't be treated surgically.
•5. ECOG PS of 0-2;
•6. Women of childbearing age had negative pregnancy tests and were willing to accept drugs or intrauterine contraception, while men of childbearing age were willing to accept contraception voluntarily.
•7. Adequate hematologic function:
•Peripheral blood neutrophil count \> 2000 cells / uL, Platelet count \> 100\*109 / L; Hemoglobin \>9.0g/dL;
•8. Blood total bilirubin \< 2 times normal upper limit, blood AST and ALT ≤ 2. 5 times normal upper line;
•9. Inosine clearance ≥ 60ml / min;
+1 more criteria

Exclusion Criteria

•1. With severe or uncontrolled systemic diseases;
•2. With a history of asthma, systemic immune diseases, such as the need for long-term hormone treatment in patients;
•3. The lung function decreased obviously;
•4. Those receiving targeted therapy or biological therapy at the same time;
•5. Allergic to beclomethasone propionate;
•6. Pregnant or lactating women;
•7. Accompanied by uncontrolled diabetes, need to take oral hormone treatment of sarcoidosis and vasculitis, lupus erythematosus and other immune diseases;
•8. In recent 5 years has suffered from other tumors: cervical cancer, basal cell carcinoma of the skin, and so on;
•9. The estimated survival time was less than 3 months.

Locations (1)

Medical Department, Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, China

Key Dates

Start Date

April 1, 2019

Primary Completion Date

September 30, 2020

Completion Date

December 30, 2020

Last Updated

March 26, 2019

Enrollment

194

ESTIMATED participants

Conditions

Locally Advanced Non Small Cell Lung Cancer

Interventions

Beclomethasone propionate

DRUG

Contacts

caicun zhou, phD MD

CONTACT

8621-65115006-3050 caicunzhoudr@126.com

jie zhang, MD

CONTACT

13501878890 zhangjie2172@163.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 26, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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