Modified Bufei Decoction to relieve post-surgery symptoms and support recovery for older lung cancer patients
A Randomized Controlled Multicenter Study on the Improvement of Postoperative Symptoms and Survival Benefits of Modified Bufei Decoction in Elderly Patients With Lung Cancer Undergoing Radical Surgery
This trial tests whether taking modified Bufei Tang granules twice daily for 28 days can reduce post-surgery cough, breathlessness, and fatigue in people aged 65 and older who had lung cancer surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 174 (estimated) |
| Ages | 65 Years and up |
| Sex | All |
| Sponsor | Peking University Cancer Hospital & Institute Academic / other |
| Locations | 2 sites (Beijing, Beijing Municipality and 1 other locations) |
| Trial ID | NCT06674252 on ClinicalTrials.gov |
What this trial studies
This multicenter, randomized, double-blind, placebo-controlled trial enrolls older patients with persistent postoperative symptoms after lung cancer resection and randomizes them 1:1 to active Jiawei Bufei Tang granules or matching placebo. Treatment begins around day 7 after surgery and continues for 28 days, with one packet taken orally twice a day. Symptom changes are measured using the MDASI-TCM scale for cough, shortness of breath, and fatigue before and after treatment to compare differences between groups. The herbal formula is provided as standardized non-decoction granules and the placebo is matched for appearance and taste to preserve blinding.
Who should consider this trial
Good fit: Ideal candidates are patients aged 65 or older who have confirmed postoperative lung cancer, meet the MDASI-TCM symptom thresholds (any one of cough, fatigue, shortness of breath ≥4 or the three combined ≥6), have generally stable heart and liver/kidney labs, and fit the TCM pattern of lung‑and‑kidney deficiency.
Not a fit: Patients with severe pulmonary infections, significant psychiatric illness or depression, those without the target post-operative symptoms, or those with unstable organ function are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If effective, the herbal treatment could reduce common post-surgery symptoms like cough, breathlessness, and fatigue and improve short-term recovery and quality of life.
How similar studies have performed: Related traditional Chinese medicine formulations have shown mixed results in small trials, and high-quality randomized evidence for this specific formula is limited, so the approach is promising but not yet proven.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria:
* Patients with postoperative lung cancer who have clear histological or cytological diagnosis.
* Age ≥ 65 years old, both male and female are eligible. According to the MDASI-TCM scale evaluation, any of the three symptoms of cough, fatigue, and shortness of breath should score ≥ 4 points, or the sum of the three should score ≥ 6 points.
* The heart function is basically normal; ALT/AST is within 2 times the normal value; SCr is within the normal range.
Traditional Chinese medicine syndrome differentiation is characterized by deficiency of both lungs and kidneys.
Exclusion Criteria:
* Patients with severe pulmonary infections. ⑵. Patients with mental illness. ⑶. Patients with depression.
Where this trial is running
Beijing, Beijing Municipality and 1 other locations
- Beijing cancer hospital — Beijing, Beijing Municipality, China (Recruiting)
- Beijing cancer hospital — Beijing, Beijing Municipality, China (Recruiting)
Study contacts
- Study coordinator: Xu yi chen, MD
- Email: xxxxyc@126.com
- Phone: 0086+15801096968
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.