Using Babaodan Capsules to Prevent Radiation Pneumonia
The Efficacy of Babaodan Capsules in Preventing Radiation Pneumonitis in Locally Advanced Non-Small Cell Lung Cancer Patients: A Phase II Clinical Trial
This study is testing if Babaodan capsules can help prevent radiation pneumonia in patients with advanced lung cancer who are getting radiation and chemotherapy.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 17 Years to 70 Years |
| Sex | All |
| Sponsor | Fifth Affiliated Hospital, Sun Yat-Sen University Academic / other |
| Drugs / interventions | radiation, chemotherapy |
| Locations | 1 site (Zhuhai, Guangdong) |
| Trial ID | NCT06079931 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of Babaodan capsules in preventing radiation pneumonitis in patients undergoing treatment for locally advanced non-small cell lung cancer (NSCLC). It focuses on patients receiving concurrent radiotherapy and chemotherapy, aiming to reduce the incidence of symptomatic pneumonia. The research will assess the impact of Babaodan on inflammatory responses associated with radiation-induced lung injury, particularly the release of pro-inflammatory cytokines. The study is designed as a Phase 2 interventional trial.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 to 70 with histologically confirmed inoperable stage IIIA or IIIB NSCLC and an ECOG performance status of 2 or less.
Not a fit: Patients with malignant pleural effusion, active uncontrolled infections, or significant cardiovascular disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce the incidence of radiation pneumonia in NSCLC patients, improving their overall treatment outcomes.
How similar studies have performed: While there is limited data on the specific use of Babaodan capsules for this purpose, the approach of using traditional Chinese medicine to mitigate radiation-induced complications is gaining interest, though it remains largely untested in this specific context.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Zhuhai, Guangdong
- The Fifth Affiliated Hospital of Sun Yat-sen University — Zhuhai, Guangdong, China (Recruiting)
Study contacts
- Study coordinator: Yulong Zhang, Dr
- Email: zhongxiyi1101@163.com
- Phone: 18810550602
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.