Study of Modified Bufei Decoction to Improve Symptoms and Survival in Elderly Lung Cancer Patients After Surgery

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 researchers 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.

A Study on the Improvement of Postoperative Symptoms and Survival Benefits of Modified Bufei Decoction in Elderly Patients With Lung Cancer Undergoing Radical Surgery