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

NCT05704166 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 214

Last updated 2025-08-08

No results posted yet for this study

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

Conditions

  • Acute Lung Injury
  • Prevention

Interventions

DRUG

Pirfenidone/Placebo

Patients were given drugs orally one week before radiotherapy, 200mg/ time, 3 times a day in the first week; 300mg/ time 3 times daily for the second week and 400mg/ time 3 times daily for the third to eighth week. Take it after a meal.

Sponsors & Collaborators

  • Beijing Continent Pharmaceutical Co, Ltd.

    collaborator INDUSTRY

  • Fujian Medical University Union Hospital

    lead OTHER

Principal Investigators

  • Yong Yang, Doctor · Director of the radiotherapy department

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-16
Primary Completion
2025-12-31
Completion
2026-05-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05704166 on ClinicalTrials.gov