Prevention of Locally Advanced NSCLC Radiotherapy Pneumonia by Inhaling Beclomethasone Propionate

NCT03886441 | Unknown Phase 2

• 1 other identifier: fk1416
• Study Type: interventional
• Target: 194
• Locations: 1 country
• Sites: 1

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.

Conditions

Locally Advanced Non Small Cell Lung Cancer

Keywords

beclomethasone propionate; radiation pneumonitis; NSCLC; radical radiotherapy; Preventive effect

Outcome Measures

Primary Outcomes (1)

• Incidence of radiation pneumonia between two groups of patients

  To evaluate the incidence of radiation pneumonia in 36weeks since thoracic irradiation between two groups of patients

  Chest CT assessment every 6 weeks since thoracic irradiation, up to 36 weeks.

Secondary Outcomes (2)

• Objective Response Rate between two groups of patients

  tumor assessment every 6 weeks since thoracic irradiation , up to 36 weeks.

• Side effects between two groups of patients

  36 weeks .

Other Outcomes (1)

• Quality of life between two groups of patients

  36 weeks

Study Arms (2)

Prevention group

EXPERIMENTAL

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

Drug: Beclomethasone propionate

Traditional therapy group

NO INTERVENTION

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

Interventions

Beclomethasone propionate DRUG

Beclomethasone propionate inhaled twice daily during radiotherapy

Prevention group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The subjects understood the requirements and risks of the study fully and signed the informed consent form.
• Aged between 18 and 70 years;
• Histologically or cytologically confirmed diagnosis of locally advanced non-small cell lung cancer.
• All of these patients have pointers to radical radiation and can't be treated surgically.
• ECOG PS of 0-2;
• 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.
• Adequate hematologic function:
• Peripheral blood neutrophil count \> 2000 cells / uL, Platelet count \> 100\*109 / L; Hemoglobin \>9.0g/dL;
• Blood total bilirubin \< 2 times normal upper limit, blood AST and ALT ≤ 2. 5 times normal upper line;
• Inosine clearance ≥ 60ml / min;
• Life expectancy of at least 12weeks.

You may not qualify if:

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

Sponsors & Collaborators

• Tongji University: lead
• Shanghai Pulmonary Hospital, Shanghai, China: collaborator

Study Sites (1)

Medical Department, Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, 200433, China

Location

MeSH Terms

Conditions

Radiation Pneumonitis

Interventions

beclomethasone 17-monopropionate

Condition Hierarchy (Ancestors)

Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases; Lung Injury; Radiation Injuries; Wounds and Injuries

Study Officials

• caicun zhou, phD MD

  Shanghai Pulmonary Hospital, Tongji University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

caicun zhou, phD MD

CONTACT

8621-65115006-3050; caicunzhoudr@126.com

jie zhang, MD

CONTACT

13501878890; zhangjie2172@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, doctor

Study Record Dates

• First Submitted: March 14, 2019
• First Posted: March 22, 2019
• Study Start: April 1, 2019
• Primary Completion: September 30, 2020
• Study Completion: December 30, 2020
• Last Updated: March 26, 2019

Record last verified: 2019-03

Locations

CN (1)