JMIR Publications

ABSTRACT

Introduction: Lung cancer remains a major health issue in China, with cancer-related deaths reaching over 2.3 million in 2020, marking a 21.6% increase compared to 2005. Tracheal, bronchial, and lung cancers are the leading causes of death for both men and women. Most cases of lung cancer are diagnosed at advanced stages, making early diagnosis critical. The widespread use of low-dose computed tomography (LDCT) has increased the detection of pulmonary nodules, but most of these are benign. Pulmonary nodules are categorized based on size and structure, and while the practice of surgically removing them remains debated, there is a need for clinical interventions to alleviate the psychological distress of patients. Many patients suffer from anxiety and depression, which can negatively affect their health. Traditional Chinese Medicine (TCM) has shown promise in treating these nodules.Yifei Sanjie Pill (YFSJ), a TCM used to treat non-small cell lung cancer (NSCLC), has demonstrated efficacy in regulating endoplasmic reticulum stress and inhibiting cell proliferation. However, its role in treating pulmonary nodules is yet to be fully explored. Method: This study will conduct a randomized controlled trial (RCT) to evaluate the efficacy of YFSJ in preventing the progression of high-risk pulmonary nodules. The trial will enroll 600 patients, divided into an experimental group (YFSJ) and a control group (placebo), with a primary endpoint of the 2-year progression rate of pulmonary nodules. Inclusion criteria focus on patients aged 18-80 with ground-glass pulmonary nodules ≤8mm, while those with severe comorbidities, advanced cancer, or mental health issues are excluded. Treatment will consist of YFSJ granules in the experimental group and placebo granules in the control group, both taken twice daily for six months. The study will be double-blind, with outcomes evaluated through lung nodule progression, symptom scales, and quality of life measures. Safety will be monitored through adverse events and clinical assessments. Plasma samples will be collected to explore the biological mechanisms involved. Statistical analysis will include descriptive statistics, Cox regression for progression rates, and mixed-effects models for quality of life indicators. The study aims to assess the safety, efficacy, and potential biological mechanisms of YFSJ in preventing the progression of high-risk pulmonary nodules. Trial registration:This project has been registered in the Chinese Clinical Trial Registry (ChiCTR) with registration number ChiCTR2300069570 Funding : Sources and Types of Financial, Material, and Other Support: the study is funded by the National Key Research and Development Program of China (Project Number: 2022YFC3500002).