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The Efficacy of Babaodan Capsules in Preventing Radiation Pneumonitis in Locally Advanced Non-Small Cell Lung Cancer Patients: A Phase II Clinical Trial

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What is being tested

Babaodan Capsule

Drug
Who is being recruted

Lung Diseases+4

+ Radiation Injuries

+ Respiratory Tract Diseases

From 17 to 70 Years
+2 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Prevention Study

Phase 2
Interventional
Study Start: December 2024
See protocol details

Summary

Principal SponsorFifth Affiliated Hospital, Sun Yat-Sen University
Study ContactYulong Zhang, Dr
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: December 5, 2024

Actual date on which the first participant was enrolled.

This clinical trial is focused on finding out if Babaodan (BBD) capsules can help prevent lung problems, specifically radiation pneumonia, in patients with locally advanced non-small cell lung cancer who are receiving radiation therapy. Radiation therapy can cause lung injury, which happens in two stages: early-stage inflammation known as radiation pneumonia, and later-stage lung scarring called pulmonary fibrosis. These lung issues are caused by the body's reaction to radiation, which can damage cells and lead to inflammation. By studying the effects of BBD, which is known to have anti-inflammatory properties, the trial aims to discover if it can reduce the risk of these lung complications and improve the treatment outcomes for these cancer patients. Participants in this study will take BBD capsules while they receive their standard cancer treatment, which includes both chemotherapy and radiation therapy. The BBD capsules are taken orally and are given during and after the radiation treatment. Researchers will observe the patients to see if BBD helps in reducing the symptoms of radiation pneumonia and if it affects the overall health of the patients by minimizing side effects. The study aims to measure the incidence and severity of lung problems during and after the treatment period to see if BBD offers a protective effect against radiation-induced lung damage.

Official TitleThe Efficacy of Babaodan Capsules in Preventing Radiation Pneumonitis in Locally Advanced Non-Small Cell Lung Cancer Patients: A Phase II Clinical Trial
NCT06079931
Principal SponsorFifth Affiliated Hospital, Sun Yat-Sen University
Study ContactYulong Zhang, Dr
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

30 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Prevention Study

Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 17 to 70 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Lung DiseasesRadiation InjuriesRespiratory Tract DiseasesWounds and InjuriesLung Diseases, InterstitialRadiation PneumonitisLung Injury

Criteria

1 inclusion criteria required to participate
(1)18 to 70 years;(2)Histologically/cytologically confirmed NSCLC;(3)ECOG ≤2;(4)Weight loss ≤10%;(5) Inoperable AJCC stage IIIA, or IIIB disease;(6)Neutrophils ≥1.5×10^9/L and platelets ≥100×10^9/L;(7)Adequate liver and renal function.

1 exclusion criteria prevent from participating
(1)Malignant pleural effusion;(2)Active uncontrolled infection;(3)Significant cardiovascular disease;(4)History of other malignancies;(5)Forced expiratory volume in 1 second <40% of normal;(6)Previous history of cervical and chest radiation therapy.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
60-66Gy/30-33F radiotherapy, 2Gy/dose; During radiation therapy, concurrent chemotherapy including paclitaxel 45 mg/m2 and carboplatin (AUC 2) was administered once a week on the first day. From the start of radiation therapy to the completion of concurrent chemoradiotherapy (CCRT) for 2 months, the patient took 2 capsules of Babaodan orally every day, tid (1.8 g/day). Systemic corticosteroids can be used in patients with acute radiation pneumonia with G ≥ 2.

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

The Fifth Affiliated Hospital of Sun Yat-sen University

Zhuhai, ChinaOpen The Fifth Affiliated Hospital of Sun Yat-sen University in Google Maps
SuspendedOne Study Center