The Effect of Comprehensive Rehabilitation Program plus Chemotherapy on Quality of Life of Patients with Postoperative Non-Small Cell Lung Cancer: A study protocol of 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. In the present study, a more rational and effective therapeutic scheme is to be applied to assess the effects of comprehensive rehabilitation program based on CHM and Liuzijue (LZJ) exercise combined with adjuvant chemotherapy on patients with postoperative non-small cell lung cancer (NSCLC). Methods: A multi-center, randomized clinical trial is to be performed 354 Ib-IIIa NSCLC patients in 5 centers in China. Patients satisfying the inclusion criteria are to be randomly divided into 3 group according to the ratio of 1:1:1, namely intervention group A (IGA), intervention group B (IGB) and controlled group (CG). Each group will receive adjuvant platinum-based doublet chemotherapy for 4 cycles. IGA participants receive chemotherapy combined with CHM and LZJ exercise, IGB participants receive chemotherapy combined with CHM and rehabilitation education, and CG participants receive chemotherapy combined with placebo and rehabilitation education. The primary outcome is QoL (The European Organization for Research and Treatment of Cancer: EORTC QLQ LC43), the secondary outcomes include: (1)2 years disease-free survival rate and disease-free survival (DFS); (2) TCM symptoms; (3) tumor markers; (4) safety and adverse events (NCI CTC version 4.0). Discussion: Our previous study reported that TCM in combination with chemotherapy could lower the overall incidence of adverse events but increase the digestive and gastrointestinal (GI) side effects than chemotherapy alone in postoperative NSCLC. The study is to lay a basis for the effectiveness of chemotherapy with or without comprehensive rehabilitation program in QoL for patients with postoperative NSCLC. Trial Registration: ClinicalTrials.gov, NCT03372694. Registered on 17 December 2018 - Retrospectively registered, https://clinicaltrials.gov/ct2/show/NCT03372694. Keywords: Chinese herbal Medicine; Liuzijue exercise; Rehabilitation; Non-small cell lung cancer; Quality of Life.