Department of Oncology, Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, 110 Ganhe Rd, Shanghai, 200437, China.
Institute of Clinical Immunology, Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, 200437, China.
Trials. 2020 Apr 3;21(1):309. doi: 10.1186/s13063-020-4162-1.
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.
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.
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.
ClinicalTrials.gov, NCT03372694. Retrospectively registered on 17 December 2018.
在中国，基于中医（TCM）的综合康复疗法已广泛应用于各种癌症治疗。到目前为止，中草药（CHM）已被证明可有效减轻化疗的不良反应，并改善化疗期间的生活质量（QoL）。本研究的目的是比较 CHM 加 Liu Zi Jue（LZJ）运动与 CHM 加康复教育以及安慰剂加康复教育在接受非小细胞肺癌（NSCLC）完全切除术后接受术后辅助化疗的患者中的作用。
将在中国的五个中心进行一项多中心、随机临床试验，共纳入 354 例 Ib-IIIa 期 NSCLC 患者。符合纳入标准的患者将按照 1:1:1 的比例随机分为三组：干预组 A（IGA）、干预组 B（IGB）和对照组（CG）。每组均接受含铂双药化疗共 4 个周期。IGA 组患者接受化疗联合 CHM 和 LZJ 运动，IGB 组患者接受化疗联合 CHM 和康复教育，CG 组患者接受化疗联合安慰剂和康复教育。接受草药治疗的患者每天服用颗粒，化疗期间每周进行 4 次 LZJ 运动。主要结局指标是生活质量，每个周期采用欧洲癌症研究与治疗组织（EORTC）-QLQ-C43 量表进行评估。次要结局指标包括 2 年无病生存率、无病生存率、中医症状、肿瘤标志物、安全性和不良事件。治疗结束后，患者将在 2 年内每 3 个月、2 年后每 6 个月进行随访，直至疾病复发和/或转移。
我们之前的研究报告称，与单独化疗相比，CHM 联合化疗可降低术后 NSCLC 患者不良反应的总发生率，但增加了消化和胃肠道副作用。本研究将为术后 NSCLC 患者化疗联合或不联合综合康复方案对生活质量的有效性奠定基础。
ClinicalTrials.gov，NCT03372694。于 2018 年 12 月 17 日回顾性注册。
