The Efficacy of Babaodan Capsules in Preventing Radiation Pneumonitis in Locally Advanced Non-Small Cell Lung Cancer Patients: A Phase II Clinical Trial
Babaodan Capsule
Lung Diseases+4
+ Radiation Injuries
+ Respiratory Tract Diseases
Prevention Study
Summary
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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.30 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Prevention Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.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
Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy 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
The Fifth Affiliated Hospital of Sun Yat-sen University
Zhuhai, ChinaOpen The Fifth Affiliated Hospital of Sun Yat-sen University in Google Maps