The Efficacy of Babaodan Capsules in Preventing Radiation Pneumonia

Study Overview
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Brief Summary
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Radiation pneumonitis (RP) is a common complication of radiotherapy for thoracic tumors, and the incidence rate of grade 2 or above RP is 20% -40%; The use of antibiotics after secondary bacterial infection due to radiation pneumonia or the use of systemic glucocorticoids for radiation pneumonia itself have significant adverse effects on the survival of NSCLC patients. At present, FDA has not approved drugs to prevent the occurrence of radiation pneumonia. traditional Chinese patent Babaodan (BBD) capsule has the effect of controlling macrophages to produce proinflammatory cytokines, such as significantly inhibiting the release of IL-6. Through prospective research, this study evaluates the incidence of symptomatic pneumonia (G ≥ 2) in the treatment of locally advanced non-small cell lung cancer with BBD combined with concurrent radiotherapy and chemotherapy.

Detailed Description
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Radiation induced lung injury (RILI) is a common complication of chest radiation therapy, which can be divided into two stages, including radiation pneumonia (RP) and pulmonary fibrosis (RPF), with different clinical manifestations and occurrence times. According to the research report, the incidence rate of grade 2 or above RP is 20% -40%, and most patients have different degrees of pulmonary fibrosis in the late stage. Although these two stages are interdependent, they can be clearly separated in terms of time: RP occurs within 6 months after treatment (usually within 12 weeks), while RPF occurs after more than 1 year of treatment. RILI is believed to be caused by reactive oxygen species produced during the treatment process, which can lead to DNA damage and subsequent inflammatory reactions. After irradiation of alveolar type II cells and endothelial cells, they release pro-inflammatory cytokines, promote the activation and chemotaxis of inflammatory cells, induce macrophages to release profibrotic factors, and stimulate fibroblast proliferation to promote fibrosis. Babaodan (BBD) capsule has the effects of clearing heat and dampness, promoting blood circulation and detoxification, and treating jaundice and pain. Its characteristics are recognized as common symptoms of infectious diseases and inflammation in modern medicine. It is widely used in clinical practice to treat viral hepatitis, cholecystitis, vascular colitis, and urinary tract infections. Studies have found that BBD has a therapeutic effect on endotoxin-induced sepsis by inhibiting NLRP3 mediated activation of inflammasomes. It has also been reported that in the animal and clinical experiments of COVID-19, BBD controls macrophages to produce a large number of proinflammatory cytokines, such as significantly inhibiting the release of IL-6, thus realizing the protective effect of excessive immune response. In addition, in vivo and in vitro research results indicate that BBD can enhance the anti-tumor effect of cisplatin on non-small cell lung cancer (NSCLC). We initiated this Phase II study to evaluate the efficacy of BBD in reducing the incidence of symptomatic RP in LANSCLC patients receiving CCRT treatment. In this study, BBD was delivered during and after CCRT, assuming that BBD can alleviate the potential harmful effects of CCRT and regulate the severity of pulmonary complications.

Official Title
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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

Conditions
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Radiation Pneumonitis

Intervention / Treatment
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* Drug: Babaodan Capsule


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: （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. Exclusion Criteria: （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.

Ages Eligible for Study
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Minimum Age: 17 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Interventional Model Description: Simon's optimal two-stage design
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Babaodan combined with standard concurrent chemoradiotherapy treatment group<br>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. | Drug: Babaodan Capsule<br>* The patient received 66-66Gy/30-33F radiation therapy. During radiation therapy, concurrent chemotherapy includes receiving 45mg/m2 paclitaxel and carboplatin (AUC 2) once a week; From the start of radiation therapy to 2 months after the completion of CCRT, the patient takes 2 capsules of Babaodan orally every day, tid (1.8 g/day), and systemic corticosteroids can be used for acute radiation pneumonia patients with G ≥ 2.<br>* Other names: Babaodan;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of radiation pneumonia with G ≥ 2 | We used Simon's optimal two-stage design: the first stage requires the recruitment of at least 6 participants, of which at least 4 do not develop symptomatic radiation pneumonia. Once the goal is achieved, the second stage begins, and at least 21 more participants are recruited to achieve a total sample size of 27 patients. Overall, if at least 22 people do not experience symptomatic radiation pneumonia, the treatment plan will be considered successful. Increase the sample size by 10% to prevent falling off and insufficient statistics, so we plan to include 30 people. | 14 months |