The Efficacy of Babaodan Capsules in Preventing Radiation Pneumonia

March 18, 2024 updated by: Fifth Affiliated Hospital, Sun Yat-Sen University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Guangdong
      • Zhuhai, Guangdong, China, 519000
        • Recruiting
        • The Fifth Affiliated Hospital of Sun Yat-sen University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Babaodan combined with standard concurrent chemoradiotherapy treatment group
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
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.
Other Names:
  • Babaodan

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The incidence of radiation pneumonia with G ≥ 2
Time Frame: 14 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fifth Affiliated Hospital, Sun Yat-Sen University

Investigators

  • Study Director: Sun Yat sen University, Fifth Affiliated Hospital, Sun Yat-Sen University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 5, 2024

Primary Completion (Estimated)

September 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

October 8, 2023

First Submitted That Met QC Criteria

October 8, 2023

First Posted (Actual)

October 12, 2023

Study Record Updates

Last Update Posted (Actual)

March 20, 2024

Last Update Submitted That Met QC Criteria

March 18, 2024

Last Verified

August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZDWY.ZYZLK.004

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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