RecruitingPhase 2NCT05704166

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

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

Sponsor

Fujian Medical University Union Hospital

Enrollment

214 participants

Start Date

Mar 16, 2023

Study Type

INTERVENTIONAL

Conditions

Prevention Acute Lung Injury

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

Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether pirfenidone (a drug commonly used for lung fibrosis) can prevent acute lung injury caused by radiation therapy in women with breast cancer who are receiving hypofractionated radiation — a shorter course of radiation with higher doses per session. **You may be eligible if...** - You are a woman between 18 and 75 years old - You have been diagnosed with breast cancer (invasive or in situ) - You are scheduled to receive radiation therapy after surgery (specific regimens apply) - Your cancer is at least clinical stage 3, or meets other pathological criteria for radiation - Your blood counts (hemoglobin, white cells, platelets) and organ function meet study thresholds - Your ECOG performance score is 0–2 **You may NOT be eligible if...** - You have severe lung, liver, or kidney disease - You have active or uncontrolled infection - You are pregnant or breastfeeding - You are already taking medications that interact with pirfenidone Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPirfenidone/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.