NDLI: The effect of comprehensive rehabilitation program plus chemotherapy on quality of life in patients with postoperative non-small-cell lung cancer: study protocol of a multicenter randomized clinical trial

Content Provider	Springer Nature : BioMed Central
Author	Yao, Jialin Jiao, Lijing Yao, Yiqing Lu, Yan Shi, Jun Li, Jiaqi Chen, Peiqi Xu, Ling Gong, Yabin
Abstract	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 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 with placebo plus rehabilitation education in patients who have undergone complete resection for nonsmall-cell lung cancer (NSCLC) followed by postoperative adjuvant chemotherapy. Methods and design A multicenter, randomized clinical trial will be performed with 354 stage Ib–IIIa NSCLC patients in five centers in China. Patients satisfying the inclusion criteria will be randomly divided into three 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 four 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 four times per week during chemotherapy. The primary outcome is QoL, which will be assessed with the European Organization for Research and Treatment of Cancer (EORTC)-QLQ-C43 scale in each cycle. The secondary outcomes include the 2-year disease-free survival rate, disease-free survival, 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 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. Trial registration ClinicalTrials.gov, NCT03372694. Retrospectively registered on 17 December 2018.
Related Links	https://trialsjournal.biomedcentral.com/counter/pdf/10.1186/s13063-020-4162-1.pdf
Ending Page	10
Page Count	10
Starting Page	1
File Format	HTM / HTML
ISSN	17456215
DOI	10.1186/s13063-020-4162-1
Journal	Trials
Issue Number	1
Volume Number	21
Language	English
Publisher	BioMed Central
Publisher Date	2020-04-03
Access Restriction	Open
Subject Keyword	Medicine Public Health Biomedicine Statistics for Life Sciences Health Sciences Chinese herbal medicine Liu Zi Jue exercises Rehabilitation Nonsmall-cell lung cancer Quality of life Medicine/Public Health
Content Type	Text
Resource Type	Article
Subject	Medicine Pharmacology (medical)
Journal Impact Factor	2/2023
5-Year Journal Impact Factor	2.1/2023

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