The Efficacy of Babaodan Capsules in Preventing Radiation Pneumonia (NCT06079931) | Clinical Trial Compass
UnknownPhase 2
The Efficacy of Babaodan Capsules in Preventing Radiation Pneumonia
China30 participantsStarted 2024-12-05
Plain-language 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.
Who can participate
Age range
17 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The incidence of radiation pneumonia with G ≥ 2
Timeframe: 14 months
Trial details
NCT IDNCT06079931
SponsorFifth Affiliated Hospital, Sun Yat-Sen University