The Efficacy of Babaodan Capsules in Preventing Radiation Pneumonia
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.
Timeline
- Start
- 2024-12-05
- Primary completion
- 2025-09-01
- Completion
- 2025-12-01
Publications
- Background Dang J, Li G, Ma L, Diao R, Zang S, Han C, Zhang S, Yao L. Predictors of grade >/= 2 and grade >/= 3 radiation pneumonitis in patients with locally advanced non-small cell lung cancer treated with three-dimensional conformal radiotherapy. Acta Oncol. 2013 Aug;52(6):1175-80. doi: 10.3109/0284186X.2012.747696. Epub 2012 Dec 3.
- Background Xu Y, Zheng X, Bai X, Li P, Ma H, Wang J, Hu X, Chen M. Simultaneous integrated boost intensity-modulated radiotherapy for locally advanced non-small cell lung cancer in Chinese population: A retrospective study. Oncotarget. 2017 Jul 25;8(30):49084-49092. doi: 10.18632/oncotarget.17094.
- Background McDonald S, Rubin P, Phillips TL, Marks LB. Injury to the lung from cancer therapy: clinical syndromes, measurable endpoints, and potential scoring systems. Int J Radiat Oncol Biol Phys. 1995 Mar 30;31(5):1187-203. doi: 10.1016/0360-3016(94)00429-O.
- Background Hanania AN, Mainwaring W, Ghebre YT, Hanania NA, Ludwig M. Radiation-Induced Lung Injury: Assessment and Management. Chest. 2019 Jul;156(1):150-162. doi: 10.1016/j.chest.2019.03.033. Epub 2019 Apr 15.
- Background Barthelemy-Brichant N, Bosquee L, Cataldo D, Corhay JL, Gustin M, Seidel L, Thiry A, Ghaye B, Nizet M, Albert A, Deneufbourg JM, Bartsch P, Nusgens B. Increased IL-6 and TGF-beta1 concentrations in bronchoalveolar lavage fluid associated with thoracic radiotherapy. Int J Radiat Oncol Biol Phys. 2004 Mar 1;58(3):758-67. doi: 10.1016/S0360-3016(03)01614-6.
- Background Antonia SJ, Villegas A, Daniel D, Vicente D, Murakami S, Hui R, Yokoi T, Chiappori A, Lee KH, de Wit M, Cho BC, Bourhaba M, Quantin X, Tokito T, Mekhail T, Planchard D, Kim YC, Karapetis CS, Hiret S, Ostoros G, Kubota K, Gray JE, Paz-Ares L, de Castro Carpeno J, Wadsworth C, Melillo G, Jiang H, Huang Y, Dennis PA, Ozguroglu M; PACIFIC Investigators. Durvalumab after Chemoradiotherapy in Stage III Non-Small-Cell Lung Cancer. N Engl J Med. 2017 Nov 16;377(20):1919-1929. doi: 10.1056/NEJMoa1709937. Epub 2017 Sep 8.
- Background Lurienne L, Cervesi J, Duhalde L, de Gunzburg J, Andremont A, Zalcman G, Buffet R, Bandinelli PA. NSCLC Immunotherapy Efficacy and Antibiotic Use: A Systematic Review and Meta-Analysis. J Thorac Oncol. 2020 Jul;15(7):1147-1159. doi: 10.1016/j.jtho.2020.03.002. Epub 2020 Mar 12.
- Background Scott SC, Pennell NA. Early Use of Systemic Corticosteroids in Patients with Advanced NSCLC Treated with Nivolumab. J Thorac Oncol. 2018 Nov;13(11):1771-1775. doi: 10.1016/j.jtho.2018.06.004. Epub 2018 Jun 20.
- Background Sha S, Dong J, Wang M, Chen Z, Gao P. Risk factors for radiation-induced lung injury in patients with advanced non-small cell lung cancer: implication for treatment strategies. World J Surg Oncol. 2021 Jul 16;19(1):214. doi: 10.1186/s12957-021-02321-3.
- Background Xia C, Shi W, Zhang Y, Ding L, Gao L, Wang Q, Shao L, Dong L, Gao Y. Prevention and treatment of radiation-induced lung injury. Future Med Chem. 2020 Dec;12(23):2161-2173. doi: 10.4155/fmc-2019-0162. Epub 2020 Nov 23.
- Background Li YF, Sheng HD, Qian J, Wang Y. The Chinese medicine babaodan suppresses LPS-induced sepsis by inhibiting NLRP3-mediated inflammasome activation. J Ethnopharmacol. 2022 Jun 28;292:115205. doi: 10.1016/j.jep.2022.115205. Epub 2022 Mar 17.
- Background Qian J, Xu H, Lv D, Liu W, Chen E, Zhou Y, Wang Y, Ying K, Fan X. Babaodan controls excessive immune responses and may represent a cytokine-targeted agent suitable for COVID-19 treatment. Biomed Pharmacother. 2021 Jul;139:111586. doi: 10.1016/j.biopha.2021.111586. Epub 2021 Apr 8.
- Background Wang Q, Liu Z, Du K, Liang M, Zhu X, Yu Z, Chen R, Qin L, Li Y, Zheng Y. Babaodan inhibits cell growth by inducing autophagy through the PI3K/AKT/mTOR pathway and enhances antitumor effects of cisplatin in NSCLC cells. Am J Transl Res. 2019 Aug 15;11(8):5272-5283. eCollection 2019.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Babaodan | Traditional medicine (herbal / TCM) | 1.8 g | Oral |