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The Efficacy of Babaodan Capsules in Preventing Radiation Pneumonia

NCT06079931 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2024-03-20

No results posted yet for this study

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.

Conditions

  • Radiation Pneumonitis

Interventions

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.

Sponsors & Collaborators

  • Fifth Affiliated Hospital, Sun Yat-Sen University

    lead OTHER

Principal Investigators

  • Sun Yat sen University · Fifth Affiliated Hospital, Sun Yat-Sen University

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
17 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-05
Primary Completion
2025-09-01
Completion
2025-12-01

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06079931 on ClinicalTrials.gov