Radiation PneumonitisPhase 2NCT06079931
The Efficacy of Babaodan Capsules in Preventing Radiation Pneumonia
A Phase 2 study testing Babaodan Capsule in people with Radiation Pneumonitis, run by Fifth Affiliated Hospital, Sun Yat-Sen University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 17 to 70 years
- Conditions the study is for
- Radiation Pneumonitis
- What is being tested?
- Babaodan Capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 5 Dec 2024to 1 Dec 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- （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.
Who cannot join
- （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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The Fifth Affiliated Hospital of Sun Yat-sen University
Zhuhai, Guangdong, 519000
Qi Zeng, Doctor, 18898534065, zengqi37@mail.sysu.edu.cn
About this study
Official title: 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.
Read the 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.
- Conditions
- Radiation Pneumonitis
- Being tested
- Babaodan Capsule
- Medical subject headings
- Radiation Pneumonitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Babaodan CapsuleDrug
Also called Babaodan
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Babaodan Capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 14 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2023
- Study start5 Dec 2024 (estimated)
- Primary completion1 Sep 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Radiation PneumonitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Simon's optimal two-stage design
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fifth Affiliated Hospital, Sun Yat-Sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sun Yat sen University, Study director, Fifth Affiliated Hospital, Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06079931
- Sponsor's protocol ID
- ZDWY.ZYZLK.004
- Status last verified
- Aug 2023
- First submitted
- 8 Oct 2023
- Last updated
- 20 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 23198719Xu 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.
PubMed 28467775McDonald 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.
PubMed 7713782Hanania 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.
PubMed 30998908Barthelemy-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.
PubMed 14967431Antonia 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.
PubMed 28885881Lurienne 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.
PubMed 32173463Scott 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.
PubMed 29935305Sha 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.
PubMed 34271911Xia 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.
PubMed 33225740Li 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.
PubMed 35307576Qian 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.
PubMed 33866132Wang 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.
PubMed 31497240
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Babaodan Capsules in Preventing Radiation Pneumonitis in Locally Advanced Non-Small Cell Lung Cancer Patients: A Phase II Clinical Trial
- ClinicalTrials.gov ID
- NCT06079931
- Acronym / sponsor ID
- ZDWY.ZYZLK.004
- Conditions
- Radiation Pneumonitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Fifth Affiliated Hospital, Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 5 Dec 2024 (estimated)
- Primary completion
- 1 Sep 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 12 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Simon's optimal two-stage design
| Arm | Type | Receives |
|---|---|---|
| Babaodan combined with standard concurrent chemoradiotherapy treatment group | Experimental | Drug: Babaodan Capsule60-66Gy/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. |
Who may qualify
- Ages
- 17 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- （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.
Key exclusion criteria (1 listed)
- （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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Babaodan CapsuleAlso: BabaodanThe 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. | Drug | Babaodan combined with standard concurrent chemoradiotherapy treatment group |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2024.
- Background: PubMed 23198719Dang 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: PubMed 28467775Xu 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: PubMed 7713782McDonald 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: PubMed 30998908Hanania 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: PubMed 14967431Barthelemy-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: PubMed 28885881Antonia 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: PubMed 32173463Lurienne 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: PubMed 29935305Scott 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: PubMed 34271911Sha 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: PubMed 33225740Xia 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: PubMed 35307576Li 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: PubMed 33866132Qian 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sun Yat sen University study director
Fifth Affiliated Hospital, Sun Yat-Sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Babaodan Capsule in people with Radiation Pneumonitis, run by Fifth Affiliated Hospital, Sun Yat-Sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yulong Zhang, Dr (18810550602, zhongxiyi1101@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of radiation pneumonia with G ≥ 2 (time frame: 14 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06079931, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2024.