The Efficacy of Babaodan Capsules in Preventing Radiation Pneumonia

NCT06079931 | Unknown Phase 2

• 1 other identifier: ZDWY.ZYZLK.004
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Babaodan combined with standard concurrent chemoradiotherapy treatment group

EXPERIMENTAL

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

Interventions

Babaodan Capsule DRUG

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.

Also known as: Babaodan

Babaodan combined with standard concurrent chemoradiotherapy treatment group

Eligibility Criteria

• Age: 17 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• （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.

You may not qualify if:

• （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.

Sponsors & Collaborators

• Fifth Affiliated Hospital, Sun Yat-Sen University: lead

Study Sites (1)

The Fifth Affiliated Hospital of Sun Yat-sen University

Zhuhai, Guangdong, 519000, China

RECRUITING

Related Publications (13)

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  PMID: 23198719 BACKGROUND

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  PMID: 28467775 BACKGROUND

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  PMID: 7713782 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.

  PMID: 30998908 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.

  PMID: 14967431 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.

  PMID: 28885881 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.

  PMID: 32173463 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.

  PMID: 29935305 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.

  PMID: 34271911 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.

  PMID: 33225740 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.

  PMID: 35307576 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.

  PMID: 33866132 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.

  PMID: 31497240 BACKGROUND

MeSH Terms

Conditions

Radiation Pneumonitis

Condition Hierarchy (Ancestors)

Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases; Lung Injury; Radiation Injuries; Wounds and Injuries

Study Officials

• Sun Yat sen University

  Fifth Affiliated Hospital, Sun Yat-Sen University

  STUDY DIRECTOR

Central Study Contacts

Yulong Zhang, Dr

CONTACT

18810550602; zhongxiyi1101@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Simon's optimal two-stage design

Study Record Dates

• First Submitted: October 8, 2023
• First Posted: October 12, 2023
• Study Start: December 5, 2024
• Primary Completion: September 1, 2025
• Study Completion: December 1, 2025
• Last Updated: March 20, 2024

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)