Shenlingcao oral liquid for patients with non-small cell lung cancer receiving adjuvant chemotherapy after radical resection: A multicenter randomized controlled trial

Yanmei Liu; Xiaochao Luo; Jiali Liu; Yu Ma; Jing Tan; Wen Wang; Jian Hu; Xiangning Fu; Lin Xu; Fenglei Yu; Shidong Xu; Haitao Ma; Xiuyi Yu; Qingjun You; Zhiqiang Wang; Ling Li; Xun Zhang; Xin Sun

doi:10.1016/j.phymed.2023.154723

Shenlingcao oral liquid for patients with non-small cell lung cancer receiving adjuvant chemotherapy after radical resection: A multicenter randomized controlled trial

Phytomedicine. 2023 May:113:154723. doi: 10.1016/j.phymed.2023.154723. Epub 2023 Feb 21.

Authors

Yanmei Liu¹, Xiaochao Luo¹, Jiali Liu¹, Yu Ma¹, Jing Tan¹, Wen Wang¹, Jian Hu², Xiangning Fu³, Lin Xu⁴, Fenglei Yu⁵, Shidong Xu⁶, Haitao Ma⁷, Xiuyi Yu⁸, Qingjun You⁹, Zhiqiang Wang⁹, Ling Li¹⁰, Xun Zhang¹¹, Xin Sun¹²

Affiliations

¹ Chinese Evidence-Based Medicine Center, West China Hospital, Sichuan University, Chengdu, China; NMPA Key Laboratory for Real World Data Research and Evaluation in Hainan, Chengdu, China; Sichuan Center of Technology Innovation for Real World Data, Chengdu, China.
² Department of Thoracic Surgery, The First Affiliated Hospital, Zhejiang University, School of Medicine, Hangzhou 310003, China.
³ Department of Thoracic Surgery, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430030, China.
⁴ Department of Thoracic Surgery, Jiangsu Key Laboratory of Molecular and Translational Cancer Research, Jiangsu Cancer Hospital, Jiangsu Institute of Cancer Research, Nanjing Medical University Affiliated Cancer Hospital, Nanjing 210029, China.
⁵ Department of Thoracic Surgery, The Second Xiangya Hospital, Central South University, Changsha 410011, China.
⁶ Department of Thoracic Surgery, Harbin Medical University Cancer Hospital, Harbin 150081, China.
⁷ Department of Thoracic Surgery, Dushu Lake Hospital Affiliated to Soochow University, Suzhou, Jiangsu 215006, China.
⁸ Department of Thoracic Surgery, The First Affiliated Hospital of Xiamen University, Xiamen 361003, China.
⁹ Department of Thoracic Surgery, The Affiliated Hospital of Jiangnan University, Wuxi 214062, China.
¹⁰ Chinese Evidence-Based Medicine Center, West China Hospital, Sichuan University, Chengdu, China; NMPA Key Laboratory for Real World Data Research and Evaluation in Hainan, Chengdu, China; Sichuan Center of Technology Innovation for Real World Data, Chengdu, China. Electronic address: liling@wchscu.cn.
¹¹ Department of Thoracic Surgery, Tianjin Chest Hospital, Tianjin 300051, China. Electronic address: zhangxun69@163.com.
¹² Chinese Evidence-Based Medicine Center, West China Hospital, Sichuan University, Chengdu, China; NMPA Key Laboratory for Real World Data Research and Evaluation in Hainan, Chengdu, China; Sichuan Center of Technology Innovation for Real World Data, Chengdu, China. Electronic address: sunxin@wchscu.cn.

PMID: 36871476
DOI: 10.1016/j.phymed.2023.154723

Abstract

Background: Low quality of life (QoL) in patients with non-small cell lung cancer (NSCLC) receiving adjuvant chemotherapy after radical resection is a major global health issue. High-quality evidence for the effectiveness of Shenlingcao oral liquid (SOL) as a complementary treatment in this patients is lacking at present.

Purpose: To determine whether complementary SOL treatment in NSCLC patients receiving adjuvant chemotherapy would yield greater improvements in QoL than chemotherapy alone.

Study design: We conducted a multicenter, randomized controlled trial of stages IIA-IIIA NSCLC patients undergoing adjuvant chemotherapy in seven hospitals.

Methods: Using stratified blocks, participants were randomized in a 1:1 ratio to receive SOL combined with conventional chemotherapy or conventional chemotherapy alone. The primary outcome was the change in global QoL from baseline to the fourth chemotherapy cycle, and intention-to-treat analysis was applied with a mixed-effect model. Secondary outcomes were functional QoL, symptoms, and performance status scores at the 6-month follow-up. Missing data were handled with multiple imputation and a pattern-mixture model.

Results: Among 516 randomized patients, 446 (86.43%) completed the study. After the fourth chemotherapy cycle, in comparison with the control group, patients receiving SOL showed a lower reduction in mean global QoL (-2.76 vs. -14.11; mean difference [MD], 11.34; 95% confidence interval [CI], 8.28 to 14.41), greater improvement in physical function (MD, 11.61; 95% CI, 8.57 to 14.65), role function (MD, 10.15; 95% CI, 5.75 to 14.54), and emotional function (MD, 4.71; 95% CI, 1.85 to 7.57), and greater improvements in lung cancer-related symptoms (e.g., fatigue, nausea/vomiting, and appetite loss) and performance status during the 6-month follow-up period (treatment main effect, p < 0.05).

Conclusion: SOL treatment for NSCLC patients receiving adjuvant chemotherapy can significantly improve QoL and performance status within 6 months after radical resection.

Trial registration: ClinicalTrials.gov identifier: NCT03712969.

Keywords: Adjuvant therapy; Non-small cell lung cancer; Quality of life; Randomized controlled trial; Traditional Chinese medicine.

Publication types

Randomized Controlled Trial
Multicenter Study

MeSH terms

Antineoplastic Combined Chemotherapy Protocols / adverse effects
Carcinoma, Non-Small-Cell Lung* / drug therapy
Carcinoma, Non-Small-Cell Lung* / surgery
Chemotherapy, Adjuvant
Humans
Lung Neoplasms* / drug therapy
Lung Neoplasms* / surgery
Quality of Life

Associated data

ClinicalTrials.gov/NCT03712969