Prevention of Locally Advanced NSCLC Radiotherapy Pneumonia by Inhaling Beclomethasone Propionate

NCT ID: NCT03886441

Last Updated: 2019-03-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 194 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-01
• Study Completion Date: 2020-12-30

Brief 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.

Conditions

Locally Advanced Non Small Cell Lung Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Prevention group

Participants inhaled beclomethasone propionate aerosol daily during chest radical radiotherapy (total dose 60GY).

Group Type: EXPERIMENTAL

Beclomethasone propionate

Intervention Type: DRUG

Beclomethasone propionate inhaled twice daily during radiotherapy

Traditional therapy group

Participants were not given daily inhalation of beclomethasone propionate when undergoing radical chest radiotherapy (total dose 60GY).

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Beclomethasone propionate

Beclomethasone propionate inhaled twice daily during radiotherapy

Intervention Type: DRUG

Eligibility Criteria

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;

10. Life expectancy of at least 12weeks.

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Pulmonary Hospital, Shanghai, China

OTHER

Sponsor Role: collaborator

Tongji University

OTHER

Sponsor Role: lead

Responsible Party

Caicun Zhou

Professor, doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

caicun zhou, phD MD

Role: PRINCIPAL_INVESTIGATOR

Shanghai Pulmonary Hospital, Tongji University

Locations

Medical Department, Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, China

Countries

China

Central Contacts

caicun zhou, phD MD

Role: CONTACT

caicunzhoudr@126.com

8621-65115006-3050

jie zhang, MD

Role: CONTACT

zhangjie2172@163.com

13501878890

Other Identifiers

fk1416

Identifier Type: -

Identifier Source: org_study_id