Actively Recruiting
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
Led by Peking University Cancer Hospital & Institute · Updated on 2026-01-27
174
Participants Needed
2
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the effects of a traditional Chinese medicine formula called Jiawei Bufei Tang on elderly patients who have undergone lung cancer surgery and experience symptoms like cough, shortness of breath, and fatigue. This randomized, double-blind, placebo-controlled phase II trial focuses on improving postoperative symptoms and potentially enhancing survival benefits in this patient group. The study uses the MDASI-TCM symptom scoring system to assess symptom changes and compare outcomes between the treatment and control groups. Participants are randomly assigned to one of two groups: the treatment group receives Jiawei Bufei Tang granules, and the control group receives a placebo that looks and tastes similar. Both groups take one packet orally with water twice daily for 28 consecutive days, starting from the seventh day after surgery. The granules are produced in the same batch and packaged identically to maintain blinding. If participants experience discomfort, unblinding or withdrawal may occur based on the researcher's judgement. During the study, patients are evaluated using the MDASI-TCM scale before starting treatment and after 28 days to measure symptoms such as cough, fatigue, and shortness of breath. Additional assessments include the QLQ-C30 quality of life scale, comprehensive geriatric assessment (CGA), and disease-free survival (DFS) within the 28-day period. Participants are monitored closely throughout the treatment for safety and symptom changes. The total participation duration is approximately one month from enrollment to final evaluation.
CONDITIONS
Brief Title
A Study on the Improvement of Postoperative Symptoms and Survival Benefits of Modified Bufei Decoction in Elderly Patients With Lung Cancer Undergoing Radical Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with postoperative lung cancer who have a clear histological or cytological diagnosis.
- Age 65 years or older, both male and female are eligible.
- Symptoms of cough, fatigue, or shortness of breath scoring 4 points or higher on the MDASI-TCM scale, or a combined score of 6 points or higher.
- Heart function is basically normal.
- Liver enzymes (ALT/AST) are within two times the normal value.
- Serum creatinine (SCr) is within the normal range.
- Traditional Chinese medicine diagnosis of deficiency of both lungs and kidneys.
You will not qualify if you...
- Patients with severe pulmonary infections.
- Patients with mental illness.
- Patients with depression.
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 28 days
Participants take oral medication—either Jiawei Bufei Tang granules or placebo—twice daily for 28 days, starting on the 7th day after surgery.
Daily oral medication for 28 days starting 7 days after surgery
Trial Site Locations
Total: 2 locations
1
Beijing cancer hospital
Beijing, Beijing Municipality, China, 100142
Actively Recruiting
2
Beijing cancer hospital
Beijing, Beijing Municipality, China, 100142
Actively Recruiting
Research Team
X
Xu yi chen, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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