The Efficacy of Babaodan Capsules in Preventing Radiation Pneumonia

Trial Title: The Efficacy of Babaodan Capsules in Preventing Radiation Pneumonia

NCT ID: NCT06079931

Condition: Radiation Pneumonitis

Conditions: Official terms:
Pneumonia
Radiation Pneumonitis

Study type: Interventional

Study phase: Phase 2

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Intervention model description: Simon's optimal two-stage design

Primary purpose: Prevention

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: Babaodan Capsule
Description: 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.
Arm group label: Babaodan combined with standard concurrent chemoradiotherapy treatment group

Other name: Babaodan

Summary: 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: 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.

Criteria for eligibility:
Criteria:
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.

Gender: All

Minimum age: 17 Years

Maximum age: 70 Years

Healthy volunteers: No

Locations:

Facility:
Name: The Fifth Affiliated Hospital of Sun Yat-sen University

Address:
City: Zhuhai
Zip: 519000
Country: China

Status: Recruiting

Contact:
Last name: Qi Zeng, Doctor

Phone: 18898534065
Email: zengqi37@mail.sysu.edu.cn

Start date: December 5, 2024

Completion date: December 1, 2025

Lead sponsor:
Agency: Fifth Affiliated Hospital, Sun Yat-Sen University
Agency class: Other

Source: Fifth Affiliated Hospital, Sun Yat-Sen University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06079931