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PirfenidoneVsPlacebo as Prophylaxis Against Acute Radiation-induced Lung Injury Following HFRT in Breast Cancer Patients

Acute Lung Injury Clinical Trial

Official title:
Pirfenidone Versus Placebo as Prophylaxis Against Acute Radiation-induced Lung Injury Following Hypofractionated Radiotherapy in Breast Cancer Patients (PRILI): A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study Evaluating

Clinical Trial Summary

The incidence of chest CT manifestations of lung injury after radiotherapy for breast cancer is more than 50%. Although the prognosis and quality of life of patients are rarely affected, it is still necessary to prevent the occurrence of minor radiation lung injury with the use of more novel drugs and subsequent salvage treatment may aggravate the radiation injury. This study intends to conduct a randomized, double-blind, single-center clinical study of pirfenidone versus placebo in the prevention of acute radiation induced lung injury after breast cancer surgery

Clinical Trial Description

The incidence of chest CT manifestations of lung injury after radiotherapy for breast cancer is more than 50%. Although the prognosis and quality of life of patients are rarely affected, it is still necessary to prevent the occurrence of minor radiation lung injury with the use of more novel drugs and subsequent salvage treatment may aggravate the radiation injury. This study intends to conduct a randomized, double-blind, single-center clinical study of pirfenidone versus placebo in the prevention of acute radiation induced lung injury after breast cancer surgery.In this study, the incidence of grade 1-4 radiation lung injury was expected to be 60% in the radiotherapy alone group (placebo group), and pirfenidone capsules (experimental group) were expected to reduce the incidence of lung injury after radiotherapy to 40%. Bilateral test showed a statistical efficacy of 0.8 (α option 0.05). In this study, two independent rate comparison sample sizes were used to calculate, Binomial Enumeration method was used for 97 patients in both groups, and the expected shedding rate was 10%. 107 patients were needed in each group, and the total sample size was 214. Biological specimens are expected to be obtained from more than 100 patients. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05704166
Study type Interventional
Source Fujian Medical University Union Hospital
Contact Yong Yang, Doctor
Phone 18813019084
Email dr_yangyong1983@163.com
Status Recruiting
Phase Phase 2
Start date March 16, 2023
Completion date December 31, 2024
View Details
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