The Effect of Comprehensive Rehabilitation Program plus Chemotherapy on Quality of Life in Patients with Postoperative Non-Small-Cell Lung Cancer: A study protocol of a multi-center randomized clinical trial

Background: Comprehensive rehabilitation therapy based on traditional Chinese medicine (TCM) has been widely applied in various cancer treatments in China. Thus far, Chinese herbal medicine (CHM) has been shown to be effective in reducing the adverse effects of chemotherapy and improving the quality of life (QoL) during chemotherapy. The purpose of the present study is to compare the effects of CHM plus Liu Zi Jue (LZJ) exercises with CHM plus rehabilitation education and placebo plus rehabilitation education in patients who have undergone complete resection for non-small-cell lung cancer (NSCLC) followed by postoperative adjuvant chemotherapy. Methods and design: A multi-center, randomized clinical trial will be performed with 354 stage Ib-IIIa NSCLC patients in 5 centers in China. Patients satisfying the inclusion criteria will be randomly divided into 3 groups according to a 1:1:1 ratio, intervention group A (IGA), intervention group B (IGB) and control group (CG). Each group will receive adjuvant platinum-based doublet chemotherapy for a total of 4 cycles. IGA participants will receive chemotherapy combined with CHM and LZJ exercises, IGB participants will receive chemotherapy combined with CHM and rehabilitation education, and CG participants will receive chemotherapy combined with placebo and rehabilitation education. The herbal treatment patients will be given granules daily and LZJ exercises will be performed 4 times a week during chemotherapy. The primary outcome is QoL, which will be assessed with the EORTC (The European Organization for Research and Treatment of Cancer)-QLQ-C43 scale each cycle. The secondary outcomes include the 2-year disease-free survival rate, disease-free survival (DFS), TCM symptoms, tumor markers, safety and adverse events. After treatment, the patients will be followed up every 3 months within 2 years and every 6 months after 2 years until disease recurrence and/or metastasis. Discussion: Our previous study reported that CHM in combination with chemotherapy could lower the overall incidence of adverse events but increased digestive and gastrointestinal (GI) side effects compared with chemotherapy alone in postoperative NSCLC patients. This study will lay a foundation for the effectiveness of chemotherapy with or without a comprehensive rehabilitation program for QoL in patients with postoperative NSCLC.