Effects of Qixuekang oral liquid in leukopenia during chemotherapy and radiotherapy in patients with malignant tumors: A randomized, double-blind, placebo-controlled, multicenter study

Abstract

Objective: To assess the efficacy and safety of Qixuekang oral liquid in the treatment of leukopenia during chemotherapy and radiotherapy.

Methods: This randomized, double-blind, placebo-controlled, multicenter clinical trial was conducted between July 2018 and May 2021. A total of 234 patients with malignant tumors were enrolled from 12 medical centers. They were randomly assigned to receive either Qixuekang oral liquid or placebo in addition to standard chemotherapy and radiotherapy, with a treatment duration ≤42 days. The primary outcome was defined as the change in peripheral white blood cell (WBC) count, determined by routine laboratory hematology tests, from baseline (D-7 to D0) to Day 42 (±2 days) of dosing (D42).

Results: In the full analysis set comprising 227 patients (113 and 114 in the experimental and control groups, respectively), a significant reduction in WBC count was observed after treatment (P < .001). The experimental group exhibited a smaller reduction in WBC count than did the control group ( P = .038). In the per-protocol set (n = 188), a trend favoring the experimental group was evident, although not statistically significant (P = .091). No significant differences were observed in the vital signs, laboratory results, or adverse events between the two groups (P > .05).

Conclusion: Qixuekang oral liquid may exert a therapeutic effect in mitigating leukopenia induced by chemotherapy and radiotherapy, while exhibiting favorable safety profiles.

Keywords

Qixuekang oral liquid / Chemotherapy / Radiotherapy / Leukopenia / Malignant tumors / White blood cell count / Randomized controlled trial

Funding

The work was funded by the National Natural Science Foundation of China (81573915 and 81973640), and the Scientific and Technological Innovation Project of the China Academy of Chinese Medical Sciences (CI2021B009).

CRediT authorship contribution statement

Yafang Cai: Data curation, conceptualization, visualization, and writing ‒ original draft. Peng Xue: Project administration, supervision, investigation, and writing ‒ review & editing. Xinyu Hu: Data curation, software, and visualization. Huijie Wang: Conceptualization, data curation, and investigation. Liping Liu: Conceptualization, data curation, and investigation. Yi Li: Conceptualization, data curation, and investigation. Jun Xiao: Conceptualization, data curation, and investigation. Changgang Sun: Conceptualization, data curation, and investigation. Yufeng Wang: Conceptualization, data curation, and investigation. Shijie Zhu: Conceptualization, methodology, resources, supervision, validation, and writing ‒ review & editing.

Declaration of competing interest

The authors declare no competing interest.

Acknowledgements

We extend our sincere gratitude to all the patients and their families who participated in this study, as well as to the dedicated staff members involved in the research process. We would also like to express our thanks to Peng Wang (Yidu Central Hospital of Weifang), Lin Cui (Taizhou Second People's Hospital), Yingying Pan (Zhangjiagang Hospital of Traditional Chinese Medicine), Xifu Zheng (Weifang No.2 People's Hospital), and Hao Chen (Sinopharm Dongfeng General Hospital) for their crucial support in patient recruitment and clinical coordination at their respective centers.

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