Wang Kai-Hung, Shen Hsuan-Shu, Chu Sung-Chao, Wang Tso-Fu, Lin Ching-Wei, Huang Wei-Han, Wu Yi-Feng, Ho Ching-Chun, Pang Cheng-Yoong, Li Chi-Cheng
Department of Medical Research, Hualien Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation, Hualien, Taiwan.
Department of Chinese Medicine, Hualien Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation, Hualien, Taiwan.
JMIR Res Protoc. 2024 Mar 11;13:e55662. doi: 10.2196/55662.
In recent years, advancements in cancer treatment have enabled cancer cell inhibition, leading to improved patient outcomes. However, the side effects of chemotherapy, especially leukopenia, impact patients' ability to tolerate their treatments and affect their quality of life. Traditional Chinese medicine is thought to provide complementary cancer treatment to improve the quality of life and prolong survival time among patients with cancer.
This study aims to evaluate the effectiveness of Chinese herbal medicine (CHM) as a complementary treatment for neutropenia prevention and immunity modulation during chemotherapy in patients with breast cancer.
We will conduct a real-world pragmatic clinical trial to evaluate the effectiveness of CHM as a supplementary therapy to prevent neutropenia in patients with breast cancer undergoing chemotherapy. Patients will be classified into CHM or non-CHM groups based on whether they received CHM during chemotherapy. Using generalized estimating equations or repeated measures ANOVA, we will assess differences in white blood cell counts, absolute neutrophil counts, immune cells, and programmed cell death protein 1 (PD-1) expression levels between the 2 groups.
This study was approved by the research ethics committee of Hualien Tzu Chi Hospital (IRB 110-168-A). The enrollment process began in September 2021 and will stop in December 2024. A total of 140 patients will be recruited. Data cleaning and analysis are expected to finish in the middle of 2025.
Traditional Chinese medicine is the most commonly used complementary medicine, and it has been reported to significantly alleviate chemotherapy-related side effects. This study's findings may contribute to developing effective interventions targeting chemotherapy-related neutropenia among patients with breast cancer in clinical practice.
International Traditional Medicine Clinical Trial Registry ITMCTR2023000054; https://tinyurl.com/yc353hes.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/55662.
近年来，癌症治疗的进展已能够抑制癌细胞，从而改善患者的治疗效果。然而，化疗的副作用，尤其是白细胞减少症，会影响患者耐受治疗的能力并影响其生活质量。传统中医被认为可提供辅助癌症治疗，以改善癌症患者的生活质量并延长生存时间。
本研究旨在评估中药作为辅助治疗手段，在乳腺癌患者化疗期间预防中性粒细胞减少和调节免疫方面的有效性。
我们将进行一项真实世界的实用临床试验，以评估中药作为辅助疗法预防接受化疗的乳腺癌患者中性粒细胞减少的有效性。患者将根据化疗期间是否接受中药分为中药组或非中药组。我们将使用广义估计方程或重复测量方差分析，评估两组之间白细胞计数、绝对中性粒细胞计数、免疫细胞和程序性细胞死亡蛋白1（PD-1）表达水平的差异。
本研究已获得花莲慈济医院研究伦理委员会批准（IRB 110-168-A）。入组过程于2021年9月开始，将于2024年12月结束。共招募140名患者。数据清理和分析预计于2025年年中完成。
传统中医是最常用的补充医学，据报道它能显著减轻化疗相关的副作用。本研究结果可能有助于在临床实践中开发针对乳腺癌患者化疗相关中性粒细胞减少的有效干预措施。
国际传统医学临床试验注册中心ITMCTR2023000054；https://tinyurl.com/yc353hes。
国际注册报告识别码（IRRID）：DERR1-10.2196/55662。
